Effect of Adding GnRHa as Luteal Phase Support in Antagonist ART CyclesPhase 3NCT04087408
Role of Triptorelin 0.1 mg as a Luteal Phase Support in Assisted Reproductive Technique After Embryo Transfer : a Randomized Controlled Trial
A Phase 3 study of Effect of Adding GnRHa as Luteal Phase Support in Antagonist ART Cycles, run by Moustafa Mohammed Abouelea at 1 site in Egypt.
Trial summary
There is still controversy over the best LPS agent and protocol and its dose and duration as well as the time of initiation and cessation. There are many protocols of luteal support in assisted reproductive technology (ART) cycles. Luteal phase support with progesterone is a standard approach for ART cycles . Read more about this study
- Who is it for?
- Ages 20 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Effect of Adding GnRHa as Luteal Phase Support in Antagonist ART Cycles
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Apr 2020to 31 Dec 2022
- 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 20 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age between 20 to 40 years.
- Baseline FSH > 10 IU/L.
- Fresh stimulated cycles
- Antagonist cycles
Who cannot join
- Uterine fibroid if encroaching uterine cavity.
- Mullerian anomalies.
- Ovarian endometrioma.
- Adnexal hydrosalpinx "except after disconnection".
- Ovarian hyper stimulation syndrome (OHSS) an exaggerated systemic response to ovarian stimulation characterized by a wide spectrum of clinical and laboratory manifestations. It is classified as mild, moderate, or severe according to the degree of abdominal distention, ovarian enlargement, and respiratory, hemodynamic and metabolic complications.
- Poor responders according to bologna criteria.
- Women refused to participate in an RCT.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Medicine
Asyut
moustafa m abouelela, master, 01007015998, dr.moustafa_basha@yahoo.com
sherif m abdelmaged, doctorate, 01009536255, doctorbadran1@yahoo.com
About this study
There is still controversy over the best LPS agent and protocol and its dose and duration as well as the time of initiation and cessation.
There are many protocols of luteal support in assisted reproductive technology (ART) cycles. Luteal phase support with progesterone is a standard approach for ART cycles .
Read more
Initial studies in vitro fertilization (IVF)/intracytoplasmic sperm injection (ICSI) patients have demonstrated that the use of a GnRH agonist (GnRHa) trigger, followed by fresh transfer and a standard luteal phase support (LPS) was associated with unacceptably high rates of loss in early pregnancy compared to hCG trigger, particularly in normal responder (NR) patients.
During IVF and fresh embryo transfer, the luteal function is disrupted and the success of the treatment is critically dependent on exogenous luteal phase support
During the last decade, two different modified LPS strategies have been proposed to overcome the mentioned luteal phase deficiency. One of these approaches has been called the "European approach" in which the endogenous steroid (progesterone and estradiol) production by the corpora lutea is boosted by exogenous LH activity, i.e., LH or hCG after GnRHa trigger. The other approach has been called the "American approach" in which luteal progesterone and estradiol are administered exogenously, thus, disregarding the function of the corpora lutea.
It has been subsequently concluded that this early pregnancy loss was caused by luteal phase (LP) insufficiency, despite the use of a standard LPS package of progesterone (P) and estradiol (E2). The LP defect was primarily caused by reduced early-mid-luteal luteinizing hormone (LH) activity, resulting in a significant reduction in progesterone output by the corpora lutea (CL) as no adverse effects were seen with respect to the maturity rate of oocytes, fertilization rates, embryo quality, and reproductive outcomes during the subsequent replacement of frozen embryos derived from women who had received a GnRHa trigger .
Transvaginal progesterone is commonly used for luteal phase support. Progesterone administration is initiated on the oocyte pick-up (OPU) day and continued for 12 days, until the serum beta human chorionic gonadotropin (hCG) measurement day. However, there are conflicting results regarding the dose, route of administration (oral, subcutaneous, transvaginal), duration (until the ultrasound demonstration of heartbeat in an intrauterine gestational sac, until 10 weeks of gestation, until 12 weeks of gestation), and formulations such as synthetic or micronized types of progesterone.
A bolus of GnRHa, when administered 6 days after OPU in GnRH antagonist cycles, is able to induce a surge of pituitary gonadotropins (FSH and LH), eliciting an increase in steroid production (E2 and P) by the CL.
The exact mechanism behind the presumed beneficial effect of LP GnRHa administration remains poorly defined. It has been hypothesized that GnRHa either supports CL function by inducing LH secretion by the pituitary gonadotrophic cells or stimulates the endometrial GnRH receptors.
Tesarik postulated a direct effect of GnRHa on the embryo, as suggested by an increase in β-HCG secretion.
Importantly, there are significant differences in the early-mid-LP endocrine pattern when GnRHa triggers and hCG triggers are compared, especially in terms of LH levels. From this, it could be hypothesized that the GnRHa-triggered IVF cycle could benefit more from the addition of a bolus of GnRHa to boost the circulating endogenous LH and thus, progesterone levels around the time of implantation than the hCG triggered cycle. No studies previously investigated this issue. Therefore, the aim here was to explore a possible fine-tuning of the LPS of GnRHa-triggered IVF/ICSI cycles, using the previously suggested protocol.
Significantly increased implantation rates (IRs) were previously reported in oocyte recipients as well as in patients who were triggered with hCG, if they received a single mid-luteal bolus of GnRHa in addition to standard LPS .
A beneficial effect of a single dose of GnRH agonist administration as a luteal phase supporting agent is yet to be determined because of the wide heterogeneity of data present in literature. Well-designed randomized clinical studies are required to clarify any effect of luteal GnRH agonist addition on pregnancy outcome measures with different doses, timing, and administration routes of GnRH agonists .
Administration of 0.1 mg of the GnRH agonist triptorelin on day 3 after embryo transfer led to a significant improvement in implantation rate (12.3% vs. 7.3%) and clinical pregnancy rate (25.5% vs. 10.0%) as compared with placebo.
Luteal phase support with single-dose GnRHa might be as efficient as three doses of hCG. Large prospective, randomized-controlled studies are required comparing GnRHa and hCG for luteal phase support.
Read the detailed description
Type of the study: Open labelled randomized controlled trial
Study Setting: ART Unit, Women's Health Hospital
- Sample Size Calculation: Sample size calculation was calculated using Epi Info software (version 7). Based on previous study the pregnancy rate was 32.6% with GnRHa and 12.5% with control. Based on these percentages and with a confidence level of 95% and power of 80%, the sample size needed for the study was estimated to be 150 women (75 in each group).
Study tools :
All women scheduled for ICSI cycles in the AUH -ART unit and fulfil the above criteria will be invited to participate in the study, and subjected to the following
- A Thorough history will be taken with special emphasis on age and parity of the patients, age and duration of marriage, menstrual pattern, contraceptive history (with stress on type and duration of use), type and duration of infertility and type of previous delivery.
- Blood sampling will be performed for baseline evaluation FSH, LH, TSH and AMH on 2nd day of menses.
- Ovarian stimulation will be initiated from the day 2 of the menstrual cycle using recombinant gonadotropins 150-450 IU depending on patient age, BMI, antral follicle count and basal serum FSH.
- After 5 days, doses will be adjusted according to ovarian response. Once the leading follicle will reach a size of 14 mm, co-treatment with a GnRH antagonist will initiated and continued up until at least three follicles reached a size of 17-18 mm.
- Trigger will be done using HCG followed by OPU 36 h later.
- Retrieved oocytes will be fertilized by ICSI depending on sperm quality.
- According to the local regional policy and after an agreement between the patient and the medical team, one to three embryos will be transferred.
- For LPS, all patients will receive micronized P (400 mg/day) vaginally beginning on the day of oocyte retrieval and continuing until either end of first trimester by ultrasound or a negative pregnancy test.
- For the study group GnRH agonist 0.1 mg will be given 6 days after OPU.
- Blood sampling will be performed for progesterone within 24 h following the GnRH agonist 0.1 mg injection particularly in the study group.
- Blood sampling will be performed 14 days after OPU for Quantative BHCG.
Randomization:
Randomization will be accomplished by using cards at the time of embryo transfer; two hundred will sequentially divide into two groups. Opaque sealed envelopes will used containing 75 cards labelled control group and 75 cards labelled study group. All of envelops will mixed together randomly in a box. The cards will be pulled randomly.
- Being tested
- Effect of adding gonadotropins releasing hormone agonist to progesterone for luteal phase support in assisted reproductive technique )antagonist cycles(: a randomized controlled trial
- Keywords
- GnRHa , LPD, antagonist, progesterone and ART
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Effect of adding gonadotropins releasing hormone agonist to progesterone for luteal phase support in assisted reproductive technique )antagonist cycles(: a randomized controlled trialDrug
- Ovarian stimulation will be initiated from the day 2 of the menstrual cycle using gonadotropins 150-450 IU
- doses will be adjusted according to ovarian response. Once the leading follicle will reach a size of 14 mm, co-treatment with a GnRH antagonist will initiated and continued up until at least three follicles reached a size of 17-18 mm.
- Trigger will be done using HCG followed by OPU 36 h later.
- Retrieved oocytes will be fertilized by ICSI.
- LPS, using micronized P (400 mg/day) vaginally beginning on the day of oocyte retrieval.
- GnRH agonist 0.1 mg will be given 6 days after OPU for the study group.
- Blood sampling will be performed for progesterone within 24 h following the GnRH agonist 0.1 mg
- Quantative BHCG will be performed 14 days after OPU.
| Study group | Role | What they receive |
|---|---|---|
| control group | No intervention | 1. Ovarian stimulation will be initiated from the day 2 of the menstrual cycle using gonadotropins 150-450 IU 2. doses will be adjusted according to ovarian response. Once the leading follicle will reach a size of 14 mm, co-treatment with a GnRH antagonist will initiated and continued up until at least three follicles reached a size of 17-18 mm. 3. Trigger will be done using HCG followed by OPU 36 h later. 4. Retrieved oocytes will be fertilized by ICSI. 5. LPS, using micronized P (400 mg/day) vaginally beginning on the day of oocyte retrieval. 6 - Blood sampling will be performed for progesterone 7 days after OPU. 7-Quantative BHCG will be performed 14 days after OPU. |
| study group | Active comparator | 1. Ovarian stimulation will be initiated from the day 2 of the menstrual cycle using gonadotropins 150-450 IU
2. doses will be adjusted according to ovarian response. Once the leading follicle will reach a size of 14 mm, co-treatment with a GnRH antagonist will initiated and continued up until at least three follicles reached a size of 17-18 mm.
3. Trigger will be done using HCG followed by OPU 36 h later.
4. Retrieved oocytes will be fertilized by ICSI.
5. LPS, using micronized P (400 mg/day) vaginally beginning on the day of oocyte retrieval.
6. GnRH agonist 0.1 mg will be given 6 days after OPU.
7. Blood sampling will be performed for progesterone within 24 h following the GnRH agonist 0.1 mg
8. Quantative BHCG will be performed 14 days after OPU. Receives: Drug: Effect of adding gonadotropins releasing hormone agonist to progesterone for luteal phase support in assisted reproductive technique )antagonist cycles(: a randomized controlled trial |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ongoing clinical pregnancy rate
the number of clinical pregnancies expressed per 100 initiated cycles, aspiration cycles, or embryo transfer cycles
Measured: up to 7 weeks pregnancy
Secondary outcomes (2)
Implantation rate.
implantation rate "the number of gestational sacs observed divided by the number of embryos transferred"
Measured: up to 4 weeks of pregnancy
First trimester abortion
abortion before 12 weeks of pregnancy
Measured: up to 13 weeks of pregnancy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2019
- Study start1 Apr 2020
- Primary completion30 Jul 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Effect of Adding GnRHa as Luteal Phase Support in Antagonist ART CyclesStudies 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 3
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Moustafa Mohammed Abouelea
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Moustafa Mohammed Abouelea, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04087408
- Sponsor's protocol ID
- MMAbouelea
- Status last verified
- May 2022
- First submitted
- 9 Sep 2019
- Last updated
- 17 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Triptorelin 0.1 mg as a Luteal Phase Support in Assisted Reproductive Technique After Embryo Transfer : a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04087408
- Acronym / sponsor ID
- MMAbouelea
- Keywords
- GnRHa , LPD, antagonist, progesterone and ART
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Moustafa Mohammed AboueleaUniversity, hospital or other
- Study start
- 1 Apr 2020 (actual)
- Primary completion
- 30 Jul 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 12 Sep 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.
There is still controversy over the best LPS agent and protocol and its dose and duration as well as the time of initiation and cessation.
There are many protocols of luteal support in assisted reproductive technology (ART) cycles. Luteal phase support with progesterone is a standard approach for ART cycles .
Initial studies in vitro fertilization (IVF)/intracytoplasmic sperm injection (ICSI) patients have demonstrated that the use of a GnRH agonist (GnRHa) trigger, followed by fresh transfer and a standard luteal phase support (LPS) was associated with unacceptably high rates of loss in early pregnancy compared to hCG trigger, particularly in normal responder (NR) patients.
During IVF and fresh embryo transfer, the luteal function is disrupted and the success of the treatment is critically dependent on exogenous luteal phase support
During the last decade, two different modified LPS strategies have been proposed to overcome the mentioned luteal phase deficiency. One of these approaches has been called the "European approach" in which the endogenous steroid (progesterone and estradiol) production by the corpora lutea is boosted by exogenous LH activity, i.e., LH or hCG after GnRHa trigger. The other approach has been called the "American approach" in which luteal progesterone and estradiol are administered exogenously, thus, disregarding the function of the corpora lutea.
It has been subsequently concluded that this early pregnancy loss was caused by luteal phase (LP) insufficiency, despite the use of a standard LPS package of progesterone (P) and estradiol (E2). The LP defect was primarily caused by reduced early-mid-luteal luteinizing hormone (LH) activity, resulting in a significant reduction in progesterone output by the corpora lutea (CL) as no adverse effects were seen with respect to the maturity rate of oocytes, fertilization rates, embryo quality, and reproductive outcomes during the subsequent replacement of frozen embryos derived from women who had received a GnRHa trigger .
Transvaginal progesterone is commonly used for luteal phase support. Progesterone administration is initiated on the oocyte pick-up (OPU) day and continued for 12 days, until the serum beta human chorionic gonadotropin (hCG) measurement day. However, there are conflicting results regarding the dose, route of administration (oral, subcutaneous, transvaginal), duration (until the ultrasound demonstration of heartbeat in an intrauterine gestational sac, until 10 weeks of gestation, until 12 weeks of gestation), and formulations such as synthetic or micronized types of progesterone.
A bolus of GnRHa, when administered 6 days after OPU in GnRH antagonist cycles, is able to induce a surge of pituitary gonadotropins (FSH and LH), eliciting an increase in steroid production (E2 and P) by the CL.
The exact mechanism behind the presumed beneficial effect of LP GnRHa administration remains poorly defined. It has been hypothesized that GnRHa either supports CL function by inducing LH secretion by the pituitary gonadotrophic cells or stimulates the endometrial GnRH receptors.
Tesarik postulated a direct effect of GnRHa on the embryo, as suggested by an increase in β-HCG secretion.
Importantly, there are significant differences in the early-mid-LP endocrine pattern when GnRHa triggers and hCG triggers are compared, especially in terms of LH levels. From this, it could be hypothesized that the GnRHa-triggered IVF cycle could benefit more from the addition of a bolus of GnRHa to boost the circulating endogenous LH and thus, progesterone levels around the time of implantation than the hCG triggered cycle. No studies previously investigated this issue. Therefore, the aim here was to explore a possible fine-tuning of the LPS of GnRHa-triggered IVF/ICSI cycles, using the previously suggested protocol.
Significantly increased implantation rates (IRs) were previously reported in oocyte recipients as well as in patients who were triggered with hCG, if they received a single mid-luteal bolus of GnRHa in addition to standard LPS .
A beneficial effect of a single dose of GnRH agonist administration as a luteal phase supporting agent is yet to be determined because of the wide heterogeneity of data present in literature. Well-designed randomized clinical studies are required to clarify any effect of luteal GnRH agonist addition on pregnancy outcome measures with different doses, timing, and administration routes of GnRH agonists .
Administration of 0.1 mg of the GnRH agonist triptorelin on day 3 after embryo transfer led to a significant improvement in implantation rate (12.3% vs. 7.3%) and clinical pregnancy rate (25.5% vs. 10.0%) as compared with placebo.
Luteal phase support with single-dose GnRHa might be as efficient as three doses of hCG. Large prospective, randomized-controlled studies are required comparing GnRHa and hCG for luteal phase support.
Detailed description
Type of the study: Open labelled randomized controlled trial
Study Setting: ART Unit, Women's Health Hospital
- Sample Size Calculation: Sample size calculation was calculated using Epi Info software (version 7). Based on previous study the pregnancy rate was 32.6% with GnRHa and 12.5% with control. Based on these percentages and with a confidence level of 95% and power of 80%, the sample size needed for the study was estimated to be 150 women (75 in each group).
Study tools :
All women scheduled for ICSI cycles in the AUH -ART unit and fulfil the above criteria will be invited to participate in the study, and subjected to the following
- A Thorough history will be taken with special emphasis on age and parity of the patients, age and duration of marriage, menstrual pattern, contraceptive history (with stress on type and duration of use), type and duration of infertility and type of previous delivery.
- Blood sampling will be performed for baseline evaluation FSH, LH, TSH and AMH on 2nd day of menses.
- Ovarian stimulation will be initiated from the day 2 of the menstrual cycle using recombinant gonadotropins 150-450 IU depending on patient age, BMI, antral follicle count and basal serum FSH.
- After 5 days, doses will be adjusted according to ovarian response. Once the leading follicle will reach a size of 14 mm, co-treatment with a GnRH antagonist will initiated and continued up until at least three follicles reached a size of 17-18 mm.
- Trigger will be done using HCG followed by OPU 36 h later.
- Retrieved oocytes will be fertilized by ICSI depending on sperm quality.
- According to the local regional policy and after an agreement between the patient and the medical team, one to three embryos will be transferred.
- For LPS, all patients will receive micronized P (400 mg/day) vaginally beginning on the day of oocyte retrieval and continuing until either end of first trimester by ultrasound or a negative pregnancy test.
- For the study group GnRH agonist 0.1 mg will be given 6 days after OPU.
- Blood sampling will be performed for progesterone within 24 h following the GnRH agonist 0.1 mg injection particularly in the study group.
- Blood sampling will be performed 14 days after OPU for Quantative BHCG.
Randomization:
Randomization will be accomplished by using cards at the time of embryo transfer; two hundred will sequentially divide into two groups. Opaque sealed envelopes will used containing 75 cards labelled control group and 75 cards labelled study group. All of envelops will mixed together randomly in a box. The cards will be pulled randomly.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control group | No intervention | –1. Ovarian stimulation will be initiated from the day 2 of the menstrual cycle using gonadotropins 150-450 IU 2. doses will be adjusted according to ovarian response. Once the leading follicle will reach a size of 14 mm, co-treatment with a GnRH antagonist will initiated and continued up until at least three follicles reached a size of 17-18 mm. 3. Trigger will be done using HCG followed by OPU 36 h later. 4. Retrieved oocytes will be fertilized by ICSI. 5. LPS, using micronized P (400 mg/day) vaginally beginning on the day of oocyte retrieval. 6 - Blood sampling will be performed for progesterone 7 days after OPU. 7-Quantative BHCG will be performed 14 days after OPU. |
| study group | Active comparator | Drug: Effect of adding gonadotropins releasing hormone agonist to progesterone for luteal phase support in assisted reproductive technique )antagonist cycles(: a randomized controlled trial1. Ovarian stimulation will be initiated from the day 2 of the menstrual cycle using gonadotropins 150-450 IU 2. doses will be adjusted according to ovarian response. Once the leading follicle will reach a size of 14 mm, co-treatment with a GnRH antagonist will initiated and continued up until at least three follicles reached a size of 17-18 mm. 3. Trigger will be done using HCG followed by OPU 36 h later. 4. Retrieved oocytes will be fertilized by ICSI. 5. LPS, using micronized P (400 mg/day) vaginally beginning on the day of oocyte retrieval. 6. GnRH agonist 0.1 mg will be given 6 days after OPU. 7. Blood sampling will be performed for progesterone within 24 h following the GnRH agonist 0.1 mg 8. Quantative BHCG will be performed 14 days after OPU. |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Age between 20 to 40 years.
- Baseline FSH > 10 IU/L.
- Fresh stimulated cycles
- Antagonist cycles
Key exclusion criteria (7 listed)
- Uterine fibroid if encroaching uterine cavity.
- Mullerian anomalies.
- Ovarian endometrioma.
- Adnexal hydrosalpinx "except after disconnection".
- Ovarian hyper stimulation syndrome (OHSS) an exaggerated systemic response to ovarian stimulation characterized by a wide spectrum of clinical and laboratory manifestations. It is classified as mild, moderate, or severe according to the degree of abdominal distention, ovarian enlargement, and respiratory, hemodynamic and metabolic complications.
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 |
|---|---|---|
| Effect of adding gonadotropins releasing hormone agonist to progesterone for luteal phase support in assisted reproductive technique )antagonist cycles(: a randomized controlled trial1. Ovarian stimulation will be initiated from the day 2 of the menstrual cycle using gonadotropins 150-450 IU 2. doses will be adjusted according to ovarian response. Once the leading follicle will reach a size of 14 mm, co-treatment with a GnRH antagonist will initiated and continued up until at least three follicles reached a size of 17-18 mm. 3. Trigger will be done using HCG followed by OPU 36 h later. 4. Retrieved oocytes will be fertilized by ICSI. 5. LPS, using micronized P (400 mg/day) vaginally beginning on the day of oocyte retrieval. 6. GnRH agonist 0.1 mg will be given 6 days after OPU for the study group. 7. Blood sampling will be performed for progesterone within 24 h following the GnRH agonist 0.1 mg 8. Quantative BHCG will be performed 14 days after OPU. | Drug | study group |
Primary outcome
Ongoing clinical pregnancy rate
Time frame: up to 7 weeks pregnancy
the number of clinical pregnancies expressed per 100 initiated cycles, aspiration cycles, or embryo transfer cycles
2 secondary outcomes
Implantation rate.
Time frame: up to 4 weeks of pregnancy
First trimester abortion
Time frame: up to 13 weeks of pregnancy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2022.
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study of Effect of Adding GnRHa as Luteal Phase Support in Antagonist ART Cycles, run by Moustafa Mohammed Abouelea at 1 site in Egypt.
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 4 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 17 May 2022. 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 Egypt. 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact moustafa m abouelela, master (00201007015998, dr.moustafa_basha@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ongoing clinical pregnancy rate (time frame: up to 7 weeks pregnancy). 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 17 May 2022.