Unexplained InfertilityPhase 3NCT02739516
Dual FSH/HCG Trigger in Letrozole Stimulated Intrauterine Insemination Cycles in Women With Unexplained Infertility
A Phase 3 study testing Human chorionic gonadotropin, FSH co-trigger and Letrozole in people with Unexplained Infertility, run by Benha University.
Trial summary
The objective of this study was to evaluate the outcome of follicle stimulating hormone (FSH) co-administration with human chorionic gonadotrophins trigger for women with unexplained infertility (UEI) and assigned for letrozole (LTZ) stimulated intrauterine insemination (IUI) cycles . Read more about this study
- Who is it for?
- Ages 18 to 35 years, women only
- Conditions the study is for
- Unexplained Infertility
- What is being tested?
- Human chorionic gonadotropin, FSH co-trigger and Letrozole
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- No sites listed yet
- Study dates
- Jun 2014to Aug 2015
- Phase
- Phase 3
- 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 18 to 35 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Unexplained infertility for more than 2 years
- Normal ovulation proved by midluteal serum progesterone level >5 ng/ml,
- Patent fallopian tubes confirmed by hysterosalpingography or laparoscopy
- Normal semen analysis according to the modified World Health Organization (WHO) criteria
- Normal hormonal profile (FSH, LH, prolactin and TSH) in the early follicular phase.
Who cannot join
- Other causes of infertility ( tubal factors, polycystic ovary syndrome (PCOS), endometriosis)
- Ovarian cysts,
- FSH >10 mIU/ml.
- Previous intrauterine insemination (IUI )cycles,
- Liver or kidney diseases,
- Hypersensitivity to the used medications.
About this study
Official title: Concomitant Administration of Follicle-stimulating Hormone at the Time of Human Chorionic Gonadotropin Trigger in Letrozole Stimulated Intrauterine Insemination Cycles in Women With Unexplained Infertility
The objective of this study was to evaluate the outcome of follicle stimulating hormone (FSH) co-administration with human chorionic gonadotrophins trigger for women with unexplained infertility (UEI) and assigned for letrozole (LTZ) stimulated intrauterine insemination (IUI) cycles .
Read the detailed description
This prospective randomized controlled study included 108 women with unexplained infertility recruited among those attending the Gynecology Outpatient Clinics of, Benha University Hospital, and private settings, Alkalubia, Egypt from Jun 2013 to Aug 2015. The study protocol was approved by the Local Ethics Committee and written informed consents were taken from both partners before starting of the study.
All women received the same regimen of ovarian stimulation using Letrozole (Femara; Novartis pharma AG, Basle, Switzerland) 2.5 mg tab twice daily for 5 days starting from cycle day 3. Transvaginal ultrasound scan (TVS) was performed daily from cycle day 9 and a total of 10,000 IU of hCG (Epifasi, EPICO) was administered to those in whom at least one ovarian follicle was ≥18 mm in size. On the day of hCG administration women were randomly categorized into two groups according to a computer generated random numerical table. Envelopes containing the allocation information were chosen sequentially by patient herself in presence of her husband. Group A received FSH (urofollitropin; Fostimon, IBSA, Bazel, Swiz; 75 IU amp) 150 IU injected once on day of hCG injection and group B received no FSH on day of hCG injection. Intrauterine insemination was performed 36 hours after HCG injection. Women in both groups received luteal phase support in the form of vaginal progesterone, (Prontogest 400 mg Vaginal Pessaries, IBSA) twice a day, starting from the day after IUI and continued till the eighth week, if the pregnancy test was positive.Two weeks later, quantitative ßhCG was estimated to diagnose chemical pregnancy. However, TVS was performed 4 weeks after positive pregnancy test to confirm clinical pregnancy by the presence of gestational sac with fetal echoes and pulsation and to exclude ectopic pregnancy. All women enrolled in the study underwent the study protocol for three consecutive cycles unless got pregnant.
- Conditions
- Unexplained Infertility
- Being tested
- Human chorionic gonadotropin, FSH co-trigger, Letrozole
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Human chorionic gonadotropinDrug
In letrozole stimulated cycle; Human chorionic gonadotropin ( hCG) 10000 IU was given intramuscular when the mean ovarian follicle diameter was ≥18 mm.
FSH co-triggerDrug
In letrozole stimulated cycle; FSH (urofollitropin; Fostimon, IBSA, Bazel, Swiz; 75 IU amp) 150 IU injected once intramuscular when the mean ovarian follicle diameter was ≥18 mm.
LetrozoleDrug
Letrozole oral tablets (Femara 2.5 mg tablet; Novartis Pharma Services, Switzerland) 2.5 mg tab twice daily for 5 days from cycle day 3.
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | In letrozole stimulated cycle: On the day of ovulation trigger the patient received standard dose of Human chorionic gonadotropin (10,000 IU). Receives: Drug: Human chorionic gonadotropin; Drug: Letrozole |
| Study | Experimental | In letrozole stimulated cycle: On the day of ovulation trigger the patient received hCG 10000 IU plus FSH co-trigger (urofollitropin; Fostimon, IBSA, Bazel, Swiz; 75 IU amp) 150 IU injected once . Receives: Drug: Human chorionic gonadotropin; Drug: FSH co-trigger; Drug: Letrozole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical pregnancy rate per cycle (PR/C) and per woman (PP/W)
Achievement of clinical pregnancy defined as the presence of an intrauterine gestational sac with a pulsating fetal heart beat on ultrasound
Measured: Throughout the study completion; up to 3 months
Secondary outcomes (3)
Frequency of ovarian hyperstimulation syndrome (OHSS)
Number of participants developed ovarian hyperstimulation syndrome (OHSS) per all women received intervention
Measured: Throughout the study completion; up to 3 months
Multiple pregnancies
Number of participants had multiple pregnancy per women achieved pregnancy .
Measured: Throughout the study completion; up to 3 months
The live birth rate per woman (LB/W).
Number of live birth per women receiving intervention.
Measured: Throughout the study completion; up to 2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2016 (estimated)
- Study startJun 2014
- Primary completionAug 2015
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Unexplained InfertilityStudies of the same condition, open and under way.
- More trials run by Benha UniversityThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- Benha University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Walid Anwar Murad, Benha University
- Investigators
- Ahmed Walid Anwar Murad, MD, Principal investigator, Gynecology & Obstetric Department, Faculty of Medicine, Benha University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02739516
- Sponsor's protocol ID
- Benha 125
- Status last verified
- May 2016
- First submitted
- 14 Mar 2016
- Last updated
- 19 May 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Concomitant Administration of Follicle-stimulating Hormone at the Time of Human Chorionic Gonadotropin Trigger in Letrozole Stimulated Intrauterine Insemination Cycles in Women With Unexplained Infertility
- ClinicalTrials.gov ID
- NCT02739516
- Acronym / sponsor ID
- Benha 125
- Conditions
- Unexplained Infertility
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- Benha UniversityUniversity, hospital or other
- Study start
- Jun 2014
- Primary completion
- Aug 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 15 Apr 2016 (estimated)
- 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 objective of this study was to evaluate the outcome of follicle stimulating hormone (FSH) co-administration with human chorionic gonadotrophins trigger for women with unexplained infertility (UEI) and assigned for letrozole (LTZ) stimulated intrauterine insemination (IUI) cycles .
Detailed description
This prospective randomized controlled study included 108 women with unexplained infertility recruited among those attending the Gynecology Outpatient Clinics of, Benha University Hospital, and private settings, Alkalubia, Egypt from Jun 2013 to Aug 2015. The study protocol was approved by the Local Ethics Committee and written informed consents were taken from both partners before starting of the study.
All women received the same regimen of ovarian stimulation using Letrozole (Femara; Novartis pharma AG, Basle, Switzerland) 2.5 mg tab twice daily for 5 days starting from cycle day 3. Transvaginal ultrasound scan (TVS) was performed daily from cycle day 9 and a total of 10,000 IU of hCG (Epifasi, EPICO) was administered to those in whom at least one ovarian follicle was ≥18 mm in size. On the day of hCG administration women were randomly categorized into two groups according to a computer generated random numerical table. Envelopes containing the allocation information were chosen sequentially by patient herself in presence of her husband. Group A received FSH (urofollitropin; Fostimon, IBSA, Bazel, Swiz; 75 IU amp) 150 IU injected once on day of hCG injection and group B received no FSH on day of hCG injection. Intrauterine insemination was performed 36 hours after HCG injection. Women in both groups received luteal phase support in the form of vaginal progesterone, (Prontogest 400 mg Vaginal Pessaries, IBSA) twice a day, starting from the day after IUI and continued till the eighth week, if the pregnancy test was positive.Two weeks later, quantitative ßhCG was estimated to diagnose chemical pregnancy. However, TVS was performed 4 weeks after positive pregnancy test to confirm clinical pregnancy by the presence of gestational sac with fetal echoes and pulsation and to exclude ectopic pregnancy. All women enrolled in the study underwent the study protocol for three consecutive cycles unless got pregnant.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Drug: Human chorionic gonadotropin, Drug: LetrozoleIn letrozole stimulated cycle: On the day of ovulation trigger the patient received standard dose of Human chorionic gonadotropin (10,000 IU). |
| Study | Experimental | Drug: Human chorionic gonadotropin, Drug: FSH co-trigger, Drug: LetrozoleIn letrozole stimulated cycle: On the day of ovulation trigger the patient received hCG 10000 IU plus FSH co-trigger (urofollitropin; Fostimon, IBSA, Bazel, Swiz; 75 IU amp) 150 IU injected once . |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Unexplained infertility for more than 2 years
- Normal ovulation proved by midluteal serum progesterone level >5 ng/ml,
- Patent fallopian tubes confirmed by hysterosalpingography or laparoscopy
- Normal semen analysis according to the modified World Health Organization (WHO) criteria
- Normal hormonal profile (FSH, LH, prolactin and TSH) in the early follicular phase.
Key exclusion criteria (6 listed)
- Other causes of infertility ( tubal factors, polycystic ovary syndrome (PCOS), endometriosis)
- Ovarian cysts,
- FSH >10 mIU/ml.
- Previous intrauterine insemination (IUI )cycles,
- Liver or kidney diseases,
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 gonadotropinIn letrozole stimulated cycle; Human chorionic gonadotropin ( hCG) 10000 IU was given intramuscular when the mean ovarian follicle diameter was ≥18 mm. | Drug | Control, Study |
| FSH co-triggerIn letrozole stimulated cycle; FSH (urofollitropin; Fostimon, IBSA, Bazel, Swiz; 75 IU amp) 150 IU injected once intramuscular when the mean ovarian follicle diameter was ≥18 mm. | Drug | Study |
| LetrozoleLetrozole oral tablets (Femara 2.5 mg tablet; Novartis Pharma Services, Switzerland) 2.5 mg tab twice daily for 5 days from cycle day 3. | Drug | Control, Study |
Primary outcome
Clinical pregnancy rate per cycle (PR/C) and per woman (PP/W)
Time frame: Throughout the study completion; up to 3 months
Achievement of clinical pregnancy defined as the presence of an intrauterine gestational sac with a pulsating fetal heart beat on ultrasound
3 secondary outcomes
Frequency of ovarian hyperstimulation syndrome (OHSS)
Time frame: Throughout the study completion; up to 3 months
Multiple pregnancies
Time frame: Throughout the study completion; up to 3 months
The live birth rate per woman (LB/W).
Time frame: Throughout the study completion; up to 2 year
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 19 May 2016.
Related trials for Unexplained Infertility
Recruiting
Sperm Preparation Prior to Intrauterine Insemination Study
Infertility, Infertility Secondary
Recruiting
Hormone-free Antral Retrieval for Viable Embryo Storage & Transfer
Infertility
Active, not recruitingPhase 3
FRIEND: Fibroids and Unexplained Infertility Treatment With Epigallocatechin Gallate; A Natural CompounD in Green Tea
Leiomyoma, Uterine
Recruiting
Royal Jelly Supplementation in Unexplained Male Infertility
Unexplained Infertility, Male Infertility
Not yet recruitingObservational study
ERA in Young Primary Infertile RIF Patients
Recurrent Implantation Failure
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.
Ahmed Walid Anwar Murad, MD principal investigator
Gynecology & Obstetric Department, Faculty of Medicine, Benha University
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Human chorionic gonadotropin, FSH co-trigger and Letrozole in people with Unexplained Infertility, run by Benha University.
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 5 inclusion and 6 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 19 May 2016. Status can change between updates, so confirm with the study contact before making plans.
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 phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Clinical pregnancy rate per cycle (PR/C) and per woman (PP/W) (time frame: Throughout the study completion; up to 3 months). 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 19 May 2016.