Female InfertilityPhase 1/2CS-EOSP-ICSINCT04071574
Comparative Study on the Efficacy of Ovarian Stimulation Protocols on the Success Rate of ICSI in Female Infertility
A Phase 1/2 study testing Human Chorionic Gonadotropin (hCG), Gonadotropins and GNRH-A Triptorelin in people with Female Infertility and Female Infertility Due to Ovulatory Disorder, run by Lebanese University at 1 site in Lebanon.
Trial summary
The study will describe the effectiveness of ovarian stimulation in correlation with female infertility causes in a Lebanese population: a comparative study using 5 protocols of ovulation induction (treatment with "A" gonadotropins alone, "B" short GnRH agonist, "C" multiple-dose GnRH antagonist, "D" long GnRH agonist… Read more about this study
- Who is it for?
- Ages 21 to 44 years, women only
- Conditions the study is for
- Female Infertility, Female Infertility Due to Ovulatory Disorder, Premature Ovarian Failure
- What is being tested?
- Human Chorionic Gonadotropin (hCG), Gonadotropins and GNRH-A Triptorelin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteLebanon
- Study dates
- 1 Feb 2018to 5 May 2023
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 44 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- must not show any of the excluded criteria
- Patients affected by female infertility due to particularly Ovulatory Disorder, Premature Ovarian Failure, Polycystic Ovary Syndrome, Tubal Origin, Ectopic Pregnancy, Salpingitis, Tubal Block/Occlusion, Hydrosalpinx, Cervical/Vaginal, Endocrine, Endometriosis, Fibroids, Congenital Uterine Anomaly, Infections Uterine, and Female Infertility of Other Origin
- The selection of subjects' age must be group matched between protocols of treatment. Premature ovarian failure is defined as AMH (Anti Mullerian Hormone) ≤ 2 ng/mL.
- Willing to collaborate and to attend to the clinical follow-ups for the next three years
- Patients willing to sign informed consent
- Able and willing to comply with all study requirements
Show all 12Show fewer
- Absence of genetic causes
- Medically suitable to undergo ovarian stimulation
- Normal serum chemistry and hematology screening tests
- Negative human immunodeficiency virus (HIV), hepatitis B (HBV), hepatitis C (HCV) serology
- No history of malignancy
- Complete history \& physical examination
Who cannot join
- Subjects to be excluded from the study if the male (husband) had any male infertility problem(s)
- Patients with any genetic abnormalities
- Patients with histories of neurologic conditions including moderate or severe head injury, stroke, cerebral or bone damage or malignancies, brain abnormalities, learning disability, major medical or psychiatric illness, and metabolic/cardiovascular disease or evidence of cardiac/renal damage or malignancies, alcohol, loss of weight during the last 2 years, chemotherapy or immunosuppressive therapy.
- Women aged 45 years and older, under 21 years
Trial locations and contacts
1 site in 1 country.
Lebanon1 site
Lebanese University, faculty of sciences III
Tripoli, North Lebanon, 961
About this study
Official title: Comparative Study on the Efficacy of Ovarian Stimulation Protocols on the Success Rate of ICSI in Women With Infertility Problems
The study will describe the effectiveness of ovarian stimulation in correlation with female infertility causes in a Lebanese population: a comparative study using 5 protocols of ovulation induction (treatment with "A" gonadotropins alone, "B" short GnRH agonist, "C" multiple-dose GnRH antagonist, "D" long GnRH agonist and "E" combined protocol of GnRH antagonist and agonist) and the outcomes of ICSI. This comparative study will help clinicians to select the relevant protocol of ovarian stimulation related to the female infertility disorders.
Read the detailed description
One in six couples worldwide is affected by infertility, which defined as the inability to conceive after one year or more of regular and unprotected intercourse. It has been stated that 48.5 million couples in the world, with unprotected coitus, suffer from infertility. In about 50% of them, the infertility is due to female factors and diseases associated with the female reproductive system. Epidemiological studies show that 10 to 15% of all married couples are estimated to have infertility problems in the Middle East. Lebanon, in particular, is characterized with traditional and westernized lifestyles; It has high rates of smoking and caffeine intake, pollution and high rates of consanguinity marriage (11 to 17%), which affect considerably the conception rate.
The desire to procreate is naturally present in women all over the world. Due to various advances in medical procreation techniques, it has become possible for many women to realize their hope. Women were more likely to be psychologically distressed to infertility and suffer from poor quality of life more than men once they are diagnosed as infertile.
The causes of female infertility can have a genetic, anatomical or physiological origin. Among the most common genetic causes of female infertility are the chromosomes abnormalities: the numbers of X chromosomes, homogeneous or mosaic; other abnormalities are reciprocal translocations, Robertsonian translocations, inversions, supernumerary markers or abnormalities of the X chromosome structure. In such cases, no treatment and procreation require an egg donation. But the main causes of female infertility are physiological and anatomical, such as ovulatory disorders (25%), endometriosis (15%), pelvic adhesions (12%), tubal blockage (11%), other tubal abnormalities (11%), hyperprolactinemia (7%) and some minor causes. In addition, leiomyomas, fibroma, polyps, and tubal disease, may reduce fertility. In addition came the environmental factors (drugs, pesticides, food, tobacco ...) and there is an increase in the percentage of infertile women with advancing female age. A French national survey on lifestyles and toxic factors in infertile couples showed that in women, tobacco generates a risk twice as high as being infertile, a decrease in the ovarian reserve where the level of anti-Mullerian hormone (AMH) decreases, irregular short cycles and dysmenorrhea are also found in smokers. In addition, products contained in tobacco such as cotinine, cadmium and hydrogen peroxide are found in the follicular fluid and would be responsible for an alteration of the recovery of oocyte meiosis.
Couples who have problems with conception are referred to a medically assisted procreation (MAP) for fertility treatments. These treatments can be very stressful both psychologically and physically. Indeed, the numerous medical appointments and examinations, as well as the many bereavements and failures, experienced following repeated attempts at conception can to consume the married, social and professional life of couples. In addition, fertility issues require significant financial resources to cover the costs of fertility treatments, but also those related to the maternal and fetal complications of pregnancy, which are more frequent in the case of MAP pregnancies than in spontaneous conception.
Control of the ovarian stimulation is the key component of assisted reproductive technologies (ART) that have shifted the clinical practice of natural mono-follicular cycles into multi-follicular stimulated cycles. The increase in the number of follicles, and consequently the number of oocytes recovered, improved pregnancy rates in women undergoing In Vitro Fertilization (IVF) / Intra-Cytoplasmic Sperm Injection (ICSI), not only by increasing the number of available embryos but also by allowing embryo culture extended and allowing the selection of higher quality embryos to be transferred. However, several studies have addressed the issue of the optimal number of oocytes recovered following controlled ovarian stimulation (COS) for IVF / ICSI and demonstrated that the ovarian response is independently related to Live Birth Rate (LBR) after IVF / ICSI.
Many new treatment modalities for ovarian stimulation have been introduced over the years - often with insufficient evidence of safety and efficacy - using different compounds and regimens for ovarian stimulation, triggering oocyte maturation, interventions preceding stimulation supplementation phase. The most important clinical challenge is to find the right balance between improving the chances of success (birth of a healthy child), a reasonable cost, acceptable discomfort for the patient, and a minimal complication rate. New developments make ovarian stimulation less intense and more individualized. The choice of the ovarian stimulation protocol is one of the most important steps in IVF/ICSI treatment.
This study aims to identify and evaluate ovarian stimulation protocols applied to different patients with different causes of female infertility prior to medically assisted procreation techniques in order to know if there is a relationship between a given protocol and the result obtained for each class of infertility. Therefore, 360 ICSI in 200-300 couples will be studied in order to evaluate the link between ovarian stimulation protocols and outcomes of ICSI.
The population will be divided into 3 groups:
- Group "OD" for ovulation disorders caused by endocrine disorders such as the polycystic ovarian syndrome (PCOS) and/or premature ovarian failure (POF)
- Group "TD" for tubal disorders caused by previous ectopic pregnancy, salpingectomy, tubal obstruction and/or hydrosalpinx
- Group "UCD" for uterine and cervical disorders caused by fibroids, endometriosis, infection and/or congenital uterine anomaly (CUA)
- Conditions
- Female Infertility, Female Infertility Due to Ovulatory Disorder, Premature Ovarian Failure, Polycystic Ovary Syndrome, Female Infertility of Tubal Origin, Ectopic Pregnancy
- Being tested
- Human Chorionic Gonadotropin (hCG), Gonadotropins, GNRH-A Triptorelin, GnRH antagonist
- Keywords
- Infertility; Ovarian; Ovulation; IVF; ICSI; Gonadotropin
- Medical subject headings
- Infertility, Female, Primary Ovarian Insufficiency, Polycystic Ovary Syndrome, Pregnancy, Ectopic, Salpingitis, Endometriosis, Leiomyoma, Uterine Anomalies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Human Chorionic Gonadotropin (hCG)Drug
Also called OVITRELLE / PREGNYL
Administration of hCG (10.000IU) for ovulation triggering
GonadotropinsDrug
Also called MENOPUR
Administration of Menotropin (hMG / FSH and LH at a 1:1 ratio) (150-225IU/day)
GNRH-A TriptorelinDrug
Also called DECAPEPTYL
Administration of Triptorelin (0.1mg/day)
GnRH antagonistDrug
Also called CETROTIDE / ORGULATRON
Administration of cetrorelix (cetrotide) or ganirelix (orgulatron) (0.25mg/day)
| Study group | Role | What they receive |
|---|---|---|
| Protocol "A" | Active comparator | Protocol with gonadotropins alone without agonist or antagonist:
Gonadotropin treatment begins after spontaneous menses. The gonadotropins (e.g. Menopur, 150-225IU) are injected daily from D2/3 of the cycle (Gonadotropin dose varies based on the follicular response). The moment to trigger ovulation by administration of HCG (e.g. Ovitrelle or Pregnyl, 10.000IU) is determined by monitoring ovulation (folliculogenesis) approximately 14 days after gonadotropins regimen and the presence of at least 3 follicles with 18 mm sizes and at least the levels of E2 reaches 250-300 pg/ml. 36 h after HCG triggering, the mature oocytes are retrieved. Receives: Drug: Human Chorionic Gonadotropin (hCG); Drug: Gonadotropins |
| Protocol "B" | Active comparator | Short GnRH agonist protocol:
For the short GnRH agonist protocol, the administration of gonadotropins begins at the same time as that of the agonist, which makes it possible to take advantage of the action of endogenous gonadotropins released by the flare-up effect of the agonist. A low dose of GnRH agonist (e.g., triptorelin (Decapeptyl 0.1mg/day)) is administered in parallel to gonadotropin (e.g. Menopur, 150-225 IU) daily starting on cycle-day 2 (Gonadotropin dose varies based on the follicular development). Continual administration of GnRH agonist and gonadotropin lasts until HCG triggering (e.g. Ovitrelle or Pregnyl, 10.000IU), ~14 days post GnRH agonist regimen when follicles size reached 16-18 mm and at least the levels of E2 reaches 250-300 pg/ml. 36 h after HCG triggering, the mature oocytes are retrieved. Receives: Drug: Human Chorionic Gonadotropin (hCG); Drug: Gonadotropins; Drug: GNRH-A Triptorelin |
| Protocol "C" | Active comparator | Multiple-dose antagonist protocol:
For the GnRH antagonist protocol, a low dose of GnRH antagonist (0.25 mg/day) is administered. The protocol starts with the administration of gonadotropin (e.g. Menopur, 150-225 IU) daily which is initiated after monitoring of patients' follicles sizes on cycle-day 2/3 (Gonadotropin dose varies based on the follicular response). Almost after the 6th days of gonadotropin injection or when follicular size reaches more than or equal to 14 mm, GnRH antagonist (e.g., cetrorelix (cetrotide) or ganirelix (orgulatron) 0.25mg) begins by subcutaneous administration every day till HCG triggering (e.g. Ovitrelle or Pregnyl, 10.000IU). 36 h after HCG triggering, the mature oocytes are retrieved. Receives: Drug: Human Chorionic Gonadotropin (hCG); Drug: Gonadotropins; Drug: GnRH antagonist |
| Protocol "D" | Active comparator | Long GnRH agonist protocol:
For the long GnRH agonist protocol, a low dose of GnRH agonist (e.g., triptorelin (Decapeptyl 0.1mg)) is administered on cycle-day 21 followed by gonadotropin (e.g. Menopur, 150-225 IU) daily starting on cycle-day 2 after menses (Gonadotropin dose varies based on the follicular development). Continual administration of GnRH agonist and gonadotropin lasts until HCG triggering (e.g. Ovitrelle or Pregnyl, 10.000IU), ~14 days post GnRH agonist regimen when follicles size reached 16-18 mm. 36 h after HCG triggering, the mature oocytes are retrieved. Receives: Drug: Human Chorionic Gonadotropin (hCG); Drug: Gonadotropins; Drug: GNRH-A Triptorelin |
| Protocol "E" | Active comparator | Combined GnRH antagonist and agonist protocol:
For the combined protocol, it starts with the administration of gonadotropin (e.g. Menopur, 150-225 IU) daily which is initiated after monitoring of patients' follicles sizes on cycle-day 2/3 (Gonadotropin dose varies based on the follicular response). Almost after the 6th days of gonadotropin injection or when follicular size reaches more than or equal to 14 mm, GnRH antagonist (e.g., cetrorelix (cetrotide) or ganirelix (orgulatron) 0.25mg) begins by subcutaneous administration every day till GnRH agonist injection (e.g., triptorelin (Decapeptyl 0.1mg/day)). 36 h after agonist injection, the mature oocytes are retrieved. Receives: Drug: Gonadotropins; Drug: GNRH-A Triptorelin; Drug: GnRH antagonist |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ovulation Induction
Monitoring of Ovulation Stimulation by trans-vaginal ultrasound determining the growth, number and appearance of the ovarian follicles as well as the maturation of the endometrium (measurement of its thickness); Follicles are considered mature when their diameter is greater than 18-20mm and each of them provides 250-300pg/mL of E2. When these criteria are obtained, ovulation is triggered
Measured: 36 hours
Secondary outcomes (4)
fertilization rate
Changes in the fertilization rate
Measured: 12 months
embryo quality
Selection of embryos for transfer depending on their morphology, and the regularity of blastomers
Measured: 12 months
pregnancy rate
Determination of βHCG for positive results
Measured: 12 months
live birth rate
Calculations of live birth rate are based on the number of live births in each group divided by all live births, multiplied by 100
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2019
- Study start1 Feb 2018
- Primary completion22 Aug 2019
- Study completion5 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Female InfertilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- comparative protocols
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lebanese University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nehman Makdissy, Lebanese University
- Investigators
- Nehman Makdissy, Professor, Study chair, Lebanese UniversitySamar El Hamoui, Dr, Study director, Lebanese University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04071574
- Sponsor's protocol ID
- LU-MC-001/18
- Acronym
- CS-EOSP-ICSI
- Status last verified
- May 2023
- First submitted
- 13 Aug 2019
- Last updated
- 9 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study on the Efficacy of Ovarian Stimulation Protocols on the Success Rate of ICSI in Women With Infertility Problems
- ClinicalTrials.gov ID
- NCT04071574
- Acronym / sponsor ID
- CS-EOSP-ICSI / LU-MC-001/18
- Conditions
- Female Infertility, Female Infertility Due to Ovulatory Disorder, Premature Ovarian Failure, Polycystic Ovary Syndrome, Female Infertility of Tubal Origin, Ectopic Pregnancy
- Keywords
- Infertility; Ovarian; Ovulation; IVF; ICSI; Gonadotropin
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Lebanese UniversityUniversity, hospital or other
- Study start
- 1 Feb 2018 (actual)
- Primary completion
- 22 Aug 2019 (actual)
- Study completion
- 5 May 2023 (actual)
- First posted
- 28 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study will describe the effectiveness of ovarian stimulation in correlation with female infertility causes in a Lebanese population: a comparative study using 5 protocols of ovulation induction (treatment with "A" gonadotropins alone, "B" short GnRH agonist, "C" multiple-dose GnRH antagonist, "D" long GnRH agonist and "E" combined protocol of GnRH antagonist and agonist) and the outcomes of ICSI. This comparative study will help clinicians to select the relevant protocol of ovarian stimulation related to the female infertility disorders.
Detailed description
One in six couples worldwide is affected by infertility, which defined as the inability to conceive after one year or more of regular and unprotected intercourse. It has been stated that 48.5 million couples in the world, with unprotected coitus, suffer from infertility. In about 50% of them, the infertility is due to female factors and diseases associated with the female reproductive system. Epidemiological studies show that 10 to 15% of all married couples are estimated to have infertility problems in the Middle East. Lebanon, in particular, is characterized with traditional and westernized lifestyles; It has high rates of smoking and caffeine intake, pollution and high rates of consanguinity marriage (11 to 17%), which affect considerably the conception rate.
The desire to procreate is naturally present in women all over the world. Due to various advances in medical procreation techniques, it has become possible for many women to realize their hope. Women were more likely to be psychologically distressed to infertility and suffer from poor quality of life more than men once they are diagnosed as infertile.
The causes of female infertility can have a genetic, anatomical or physiological origin. Among the most common genetic causes of female infertility are the chromosomes abnormalities: the numbers of X chromosomes, homogeneous or mosaic; other abnormalities are reciprocal translocations, Robertsonian translocations, inversions, supernumerary markers or abnormalities of the X chromosome structure. In such cases, no treatment and procreation require an egg donation. But the main causes of female infertility are physiological and anatomical, such as ovulatory disorders (25%), endometriosis (15%), pelvic adhesions (12%), tubal blockage (11%), other tubal abnormalities (11%), hyperprolactinemia (7%) and some minor causes. In addition, leiomyomas, fibroma, polyps, and tubal disease, may reduce fertility. In addition came the environmental factors (drugs, pesticides, food, tobacco ...) and there is an increase in the percentage of infertile women with advancing female age. A French national survey on lifestyles and toxic factors in infertile couples showed that in women, tobacco generates a risk twice as high as being infertile, a decrease in the ovarian reserve where the level of anti-Mullerian hormone (AMH) decreases, irregular short cycles and dysmenorrhea are also found in smokers. In addition, products contained in tobacco such as cotinine, cadmium and hydrogen peroxide are found in the follicular fluid and would be responsible for an alteration of the recovery of oocyte meiosis.
Couples who have problems with conception are referred to a medically assisted procreation (MAP) for fertility treatments. These treatments can be very stressful both psychologically and physically. Indeed, the numerous medical appointments and examinations, as well as the many bereavements and failures, experienced following repeated attempts at conception can to consume the married, social and professional life of couples. In addition, fertility issues require significant financial resources to cover the costs of fertility treatments, but also those related to the maternal and fetal complications of pregnancy, which are more frequent in the case of MAP pregnancies than in spontaneous conception.
Control of the ovarian stimulation is the key component of assisted reproductive technologies (ART) that have shifted the clinical practice of natural mono-follicular cycles into multi-follicular stimulated cycles. The increase in the number of follicles, and consequently the number of oocytes recovered, improved pregnancy rates in women undergoing In Vitro Fertilization (IVF) / Intra-Cytoplasmic Sperm Injection (ICSI), not only by increasing the number of available embryos but also by allowing embryo culture extended and allowing the selection of higher quality embryos to be transferred. However, several studies have addressed the issue of the optimal number of oocytes recovered following controlled ovarian stimulation (COS) for IVF / ICSI and demonstrated that the ovarian response is independently related to Live Birth Rate (LBR) after IVF / ICSI.
Many new treatment modalities for ovarian stimulation have been introduced over the years - often with insufficient evidence of safety and efficacy - using different compounds and regimens for ovarian stimulation, triggering oocyte maturation, interventions preceding stimulation supplementation phase. The most important clinical challenge is to find the right balance between improving the chances of success (birth of a healthy child), a reasonable cost, acceptable discomfort for the patient, and a minimal complication rate. New developments make ovarian stimulation less intense and more individualized. The choice of the ovarian stimulation protocol is one of the most important steps in IVF/ICSI treatment.
This study aims to identify and evaluate ovarian stimulation protocols applied to different patients with different causes of female infertility prior to medically assisted procreation techniques in order to know if there is a relationship between a given protocol and the result obtained for each class of infertility. Therefore, 360 ICSI in 200-300 couples will be studied in order to evaluate the link between ovarian stimulation protocols and outcomes of ICSI.
The population will be divided into 3 groups:
- Group "OD" for ovulation disorders caused by endocrine disorders such as the polycystic ovarian syndrome (PCOS) and/or premature ovarian failure (POF)
- Group "TD" for tubal disorders caused by previous ectopic pregnancy, salpingectomy, tubal obstruction and/or hydrosalpinx
- Group "UCD" for uterine and cervical disorders caused by fibroids, endometriosis, infection and/or congenital uterine anomaly (CUA)
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
- Model description
- comparative protocols
| Arm | Type | Receives |
|---|---|---|
| Protocol "A" | Active comparator | Drug: Human Chorionic Gonadotropin (hCG), Drug: GonadotropinsProtocol with gonadotropins alone without agonist or antagonist: Gonadotropin treatment begins after spontaneous menses. The gonadotropins (e.g. Menopur, 150-225IU) are injected daily from D2/3 of the cycle (Gonadotropin dose varies based on the follicular response). The moment to trigger ovulation by administration of HCG (e.g. Ovitrelle or Pregnyl, 10.000IU) is determined by monitoring ovulation (folliculogenesis) approximately 14 days after gonadotropins regimen and the presence of at least 3 follicles with 18 mm sizes and at least the levels of E2 reaches 250-300 pg/ml. 36 h after HCG triggering, the mature oocytes are retrieved. |
| Protocol "B" | Active comparator | Drug: Human Chorionic Gonadotropin (hCG), Drug: Gonadotropins, Drug: GNRH-A TriptorelinShort GnRH agonist protocol: For the short GnRH agonist protocol, the administration of gonadotropins begins at the same time as that of the agonist, which makes it possible to take advantage of the action of endogenous gonadotropins released by the flare-up effect of the agonist. A low dose of GnRH agonist (e.g., triptorelin (Decapeptyl 0.1mg/day)) is administered in parallel to gonadotropin (e.g. Menopur, 150-225 IU) daily starting on cycle-day 2 (Gonadotropin dose varies based on the follicular development). Continual administration of GnRH agonist and gonadotropin lasts until HCG triggering (e.g. Ovitrelle or Pregnyl, 10.000IU), ~14 days post GnRH agonist regimen when follicles size reached 16-18 mm and at least the levels of E2 reaches 250-300 pg/ml. 36 h after HCG triggering, the mature oocytes are retrieved. |
| Protocol "C" | Active comparator | Drug: Human Chorionic Gonadotropin (hCG), Drug: Gonadotropins, Drug: GnRH antagonistMultiple-dose antagonist protocol: For the GnRH antagonist protocol, a low dose of GnRH antagonist (0.25 mg/day) is administered. The protocol starts with the administration of gonadotropin (e.g. Menopur, 150-225 IU) daily which is initiated after monitoring of patients' follicles sizes on cycle-day 2/3 (Gonadotropin dose varies based on the follicular response). Almost after the 6th days of gonadotropin injection or when follicular size reaches more than or equal to 14 mm, GnRH antagonist (e.g., cetrorelix (cetrotide) or ganirelix (orgulatron) 0.25mg) begins by subcutaneous administration every day till HCG triggering (e.g. Ovitrelle or Pregnyl, 10.000IU). 36 h after HCG triggering, the mature oocytes are retrieved. |
| Protocol "D" | Active comparator | Drug: Human Chorionic Gonadotropin (hCG), Drug: Gonadotropins, Drug: GNRH-A TriptorelinLong GnRH agonist protocol: For the long GnRH agonist protocol, a low dose of GnRH agonist (e.g., triptorelin (Decapeptyl 0.1mg)) is administered on cycle-day 21 followed by gonadotropin (e.g. Menopur, 150-225 IU) daily starting on cycle-day 2 after menses (Gonadotropin dose varies based on the follicular development). Continual administration of GnRH agonist and gonadotropin lasts until HCG triggering (e.g. Ovitrelle or Pregnyl, 10.000IU), ~14 days post GnRH agonist regimen when follicles size reached 16-18 mm. 36 h after HCG triggering, the mature oocytes are retrieved. |
| Protocol "E" | Active comparator | Drug: Gonadotropins, Drug: GNRH-A Triptorelin, Drug: GnRH antagonistCombined GnRH antagonist and agonist protocol: For the combined protocol, it starts with the administration of gonadotropin (e.g. Menopur, 150-225 IU) daily which is initiated after monitoring of patients' follicles sizes on cycle-day 2/3 (Gonadotropin dose varies based on the follicular response). Almost after the 6th days of gonadotropin injection or when follicular size reaches more than or equal to 14 mm, GnRH antagonist (e.g., cetrorelix (cetrotide) or ganirelix (orgulatron) 0.25mg) begins by subcutaneous administration every day till GnRH agonist injection (e.g., triptorelin (Decapeptyl 0.1mg/day)). 36 h after agonist injection, the mature oocytes are retrieved. |
Who may qualify
- Ages
- 21 to 44 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- must not show any of the excluded criteria
- Patients affected by female infertility due to particularly Ovulatory Disorder, Premature Ovarian Failure, Polycystic Ovary Syndrome, Tubal Origin, Ectopic Pregnancy, Salpingitis, Tubal Block/Occlusion, Hydrosalpinx, Cervical/Vaginal, Endocrine, Endometriosis, Fibroids, Congenital Uterine Anomaly, Infections Uterine, and Female Infertility of Other Origin
- The selection of subjects' age must be group matched between protocols of treatment. Premature ovarian failure is defined as AMH (Anti Mullerian Hormone) ≤ 2 ng/mL.
- Willing to collaborate and to attend to the clinical follow-ups for the next three years
- Patients willing to sign informed consent
Key exclusion criteria (4 listed)
- Subjects to be excluded from the study if the male (husband) had any male infertility problem(s)
- Patients with any genetic abnormalities
- Patients with histories of neurologic conditions including moderate or severe head injury, stroke, cerebral or bone damage or malignancies, brain abnormalities, learning disability, major medical or psychiatric illness, and metabolic/cardiovascular disease or evidence of cardiac/renal damage or malignancies, alcohol, loss of weight during the last 2 years, chemotherapy or immunosuppressive therapy.
- Women aged 45 years and older, under 21 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Human Chorionic Gonadotropin (hCG)Also: OVITRELLE / PREGNYLAdministration of hCG (10.000IU) for ovulation triggering | Drug | Protocol "A", Protocol "B", Protocol "C", Protocol "D" |
| GonadotropinsAlso: MENOPURAdministration of Menotropin (hMG / FSH and LH at a 1:1 ratio) (150-225IU/day) | Drug | Protocol "A", Protocol "B", Protocol "C", Protocol "D", Protocol "E" |
| GNRH-A TriptorelinAlso: DECAPEPTYLAdministration of Triptorelin (0.1mg/day) | Drug | Protocol "B", Protocol "D", Protocol "E" |
| GnRH antagonistAlso: CETROTIDE / ORGULATRONAdministration of cetrorelix (cetrotide) or ganirelix (orgulatron) (0.25mg/day) | Drug | Protocol "C", Protocol "E" |
Primary outcome
Ovulation Induction
Time frame: 36 hours
Monitoring of Ovulation Stimulation by trans-vaginal ultrasound determining the growth, number and appearance of the ovarian follicles as well as the maturation of the endometrium (measurement of its thickness); Follicles are considered mature when their diameter is greater than 18-20mm and each of them provides 250-300pg/mL of E2. When these criteria are obtained, ovulation is triggered
4 secondary outcomes
fertilization rate
Time frame: 12 months
embryo quality
Time frame: 12 months
pregnancy rate
Time frame: 12 months
live birth rate
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2023.
- Individual participant dataSharing planned: No
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Functional Hypothalamic Amenorrhea, FHA
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PRECISION-E2: Teverelix in Women With Endometriosis - Pharmacodynamics, Safety and Precision Medicine Correlates
Endometriosis Pelvic, Endometriosis Ovaries
Recruiting
Clinical Impact of Uterine Repair During Cesarean Section With Barbed Suture on the Incidence of Isthmocele
Isthmocele, Cesarean Scar Defect
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nehman Makdissy, Professor study chair
Lebanese University
Samar El Hamoui, Dr study director
Lebanese University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Human Chorionic Gonadotropin (hCG), Gonadotropins and GNRH-A Triptorelin in people with Female Infertility and Female Infertility Due to Ovulatory Disorder, run by Lebanese University at 1 site in Lebanon.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Lebanon. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ovulation Induction (time frame: 36 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2023.