PCOS GnRH Antagonist and GnRH Agonist IVF/ICSI CyclesNCT07727863
Effect of Estradiol Pretreatment on Follicular Synchronization and IVF Outcomes in Women With Polycystic Ovary Syndrome Undergoing ICSI Using GnRH Antagonist Protocol
A study testing GnRH Antagonist Protocol and Estradiol Valerate 4mg in people with PCOS GnRH Antagonist and GnRH Agonist IVF/ICSI Cycles and IVF Outcomes, run by Cairo University at 1 site in Egypt.
Trial summary
This randomized clinical trial included 60 infertile women diagnosed with PCOS undergoing ICSI cycles using a GnRH antagonist protocol. Participants were randomly allocated into two equal groups: the pretreatment (Cyclo) group (n = 30), which received oral estradiol valerate (Cycloprogynova) 4 mg/day during the luteal… Read more about this study
- Who is it for?
- Ages 20 to 37 years, women only
- Conditions the study is for
- PCOS GnRH Antagonist and GnRH Agonist IVF/ICSI Cycles, IVF Outcomes
- What is being tested?
- GnRH Antagonist Protocol and Estradiol Valerate 4mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 61 participants
- Where
- 1 siteEgypt
- Study dates
- 13 Sep 2024to 21 Jun 2026
- Phase
- Interventional
- 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 37 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- PCOS was defined by the presence of at least two of the following:
- oligo or anovulation,
- clinical or biochemical hyperandrogenism, and
- polycystic ovarian morphology on ultrasound (≥12 antral follicles 2-9 mm in diameter and/or ovarian volume >10 mL).
- All participants had undergone failed ovulation induction or were candidates for IVF/ICSI due to male factor infertility.
Who cannot join
- previous ovarian surgery
- endometriosis
- known chromosomal abnormalities
- untreated thyroid disease
- body mass index (BMI) > 35 kg/m²
- basal FSH >12 IU/L
- use of hormonal medications within 3 months prior to the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Estradiol Pretreatment on Follicular Synchronization and IVF Outcomes in Women With Polycystic Ovary Syndrome Undergoing ICSI Using GnRH Antagonist Protocol: A Randomized Clinical Trial
This randomized clinical trial included 60 infertile women diagnosed with PCOS undergoing ICSI cycles using a GnRH antagonist protocol. Participants were randomly allocated into two equal groups: the pretreatment (Cyclo) group (n = 30), which received oral estradiol valerate (Cycloprogynova) 4 mg/day during the luteal phase before stimulation, and the control group (n = 30), which did not receive pretreatment.
Primary outcomes included follicular synchronization, total gonadotropin dose, duration of stimulation, and ovarian response. Secondary outcomes included mature oocyte yield, fertilization rate, embryo quality, and pregnancy outcomes.
Read the detailed description
Controlled ovarian stimulation was initiated on day 2 of the menstrual cycle using individualized gonadotropin doses according to age, BMI, AMH, and AFC. GnRH antagonist was initiated once at least one follicle reached 13 mm diameter.
Ovulation trigger was administered when at least five follicles reached ≥17 mm. Add reference Oocyte retrieval was performed 36 hours after trigger under transvaginal ultrasound guidance.
Women in the pretreatment group received oral estradiol valerate (Cycloprogynova) 4 mg/day during the luteal phase from day 21 of prior cycle To day 2 of COH ovarian stimulation cycle while women in the control group underwent standard GnRH antagonist stimulation without estradiol pretreatment.
- Being tested
- GnRH Antagonist Protocol, Estradiol Valerate 4mg
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GnRH Antagonist ProtocolDrug
Controlled ovarian stimulation was initiated on day 2 of the menstrual cycle using individualized gonadotropin doses according to age, BMI, AMH, and AFC. GnRH antagonist was initiated once at least one follicle reached 13 mm diameter.
Estradiol Valerate 4mgDrug
oral estradiol valerate (Cycloprogynova) 4 mg/day during the luteal phase from day 21 To day 2 preceding ovarian stimulation cycle
| Study group | Role | What they receive |
|---|---|---|
| Estradiol group | Active comparator | received oral estradiol valerate (Cycloprogynova) 4 mg/day during the luteal phase from day 21 To day2 preceding ovarian stimulation cycle Receives: Drug: GnRH Antagonist Protocol; Drug: Estradiol Valerate 4mg |
| Control group | Placebo comparator | women in the control group underwent standard GnRH antagonist stimulation without estradiol pretreatment Receives: Drug: GnRH Antagonist Protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Follicular synchronization
Mean follicle diameter and within patient standard deviation
Measured: at day 8 of stimulation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2026
- Study start13 Sep 2024
- Primary completion17 Feb 2026
- Study completion21 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PCOS GnRH Antagonist and GnRH Agonist IVF/ICSI CyclesStudies of the same condition, open and under way.
- More trials run by Cairo 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed M Maged, MD, Cairo University
- Investigators
- Ahmed Maged, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07727863
- Sponsor's protocol ID
- 369
- Status last verified
- Jul 2026
- First submitted
- 16 Jul 2026
- Last updated
- 27 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Estradiol Pretreatment on Follicular Synchronization and IVF Outcomes in Women With Polycystic Ovary Syndrome Undergoing ICSI Using GnRH Antagonist Protocol: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07727863
- Acronym / sponsor ID
- 369
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 13 Sep 2024 (actual)
- Primary completion
- 17 Feb 2026 (actual)
- Study completion
- 21 Jun 2026 (actual)
- First posted
- 27 Jul 2026 (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.
This randomized clinical trial included 60 infertile women diagnosed with PCOS undergoing ICSI cycles using a GnRH antagonist protocol. Participants were randomly allocated into two equal groups: the pretreatment (Cyclo) group (n = 30), which received oral estradiol valerate (Cycloprogynova) 4 mg/day during the luteal phase before stimulation, and the control group (n = 30), which did not receive pretreatment.
Primary outcomes included follicular synchronization, total gonadotropin dose, duration of stimulation, and ovarian response. Secondary outcomes included mature oocyte yield, fertilization rate, embryo quality, and pregnancy outcomes.
Detailed description
Controlled ovarian stimulation was initiated on day 2 of the menstrual cycle using individualized gonadotropin doses according to age, BMI, AMH, and AFC. GnRH antagonist was initiated once at least one follicle reached 13 mm diameter.
Ovulation trigger was administered when at least five follicles reached ≥17 mm. Add reference Oocyte retrieval was performed 36 hours after trigger under transvaginal ultrasound guidance.
Women in the pretreatment group received oral estradiol valerate (Cycloprogynova) 4 mg/day during the luteal phase from day 21 of prior cycle To day 2 of COH ovarian stimulation cycle while women in the control group underwent standard GnRH antagonist stimulation without estradiol pretreatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Estradiol group | Active comparator | Drug: GnRH Antagonist Protocol, Drug: Estradiol Valerate 4mgreceived oral estradiol valerate (Cycloprogynova) 4 mg/day during the luteal phase from day 21 To day2 preceding ovarian stimulation cycle |
| Control group | Placebo comparator | Drug: GnRH Antagonist Protocolwomen in the control group underwent standard GnRH antagonist stimulation without estradiol pretreatment |
Who may qualify
- Ages
- 20 to 37 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- PCOS was defined by the presence of at least two of the following:
- All participants had undergone failed ovulation induction or were candidates for IVF/ICSI due to male factor infertility.
Key exclusion criteria (7 listed)
- previous ovarian surgery
- endometriosis
- known chromosomal abnormalities
- untreated thyroid disease
- body mass index (BMI) > 35 kg/m²
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 |
|---|---|---|
| GnRH Antagonist ProtocolControlled ovarian stimulation was initiated on day 2 of the menstrual cycle using individualized gonadotropin doses according to age, BMI, AMH, and AFC. GnRH antagonist was initiated once at least one follicle reached 13 mm diameter. | Drug | Control group, Estradiol group |
| Estradiol Valerate 4mgoral estradiol valerate (Cycloprogynova) 4 mg/day during the luteal phase from day 21 To day 2 preceding ovarian stimulation cycle | Drug | Estradiol group |
Primary outcome
Follicular synchronization
Time frame: at day 8 of stimulation
Mean follicle diameter and within patient standard deviation
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 27 Jul 2026.
- Individual participant dataSharing planned: Undecided
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 Maged principal investigator
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing GnRH Antagonist Protocol and Estradiol Valerate 4mg in people with PCOS GnRH Antagonist and GnRH Agonist IVF/ICSI Cycles and IVF Outcomes, run by Cairo University 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 5 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: finished, as of the sponsor's last update on 27 Jul 2026. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
Follicular synchronization (time frame: at day 8 of stimulation). 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 27 Jul 2026.