Effect of Estradiol Pretreatment on Follicular Synchronization and IVF Outcomes in Women With Polycystic Ovary Syndrome Undergoing ICSI Using GnRH Antagonist Protocol
Key facts
- Who runs it
- Cairo University
- Where
- Egypt1 site in 1 countryChoose a country to see its sites
- Trial code
- Status
- Completed
- People taking part
- 61 people enrolled
- Started
- 13 Sept 2024
- Ended
- 21 Jun 2026
- Type of study
- Interventional, 2 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- GnRH Antagonist Protocol
- Estradiol Valerate 4mg
- Record updated
- 27 July 2026
Who can take part
- Age
- 20 years to 37 years
- Sex
- Women only
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
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Who can take part
- 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 take part
- previous ovarian surgery
- use of hormonal medications within 3 months prior to the study
- untreated thyroid disease
- endometriosis
- known chromosomal abnormalities
- body mass index (BMI) > 35 kg/m²
- basal FSH >12 IU/L
This trial has no sites in United States.
It has sites in one country. Choose a country to see its sites.
About the trial
What the trial wants to find out
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.
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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.
The 2 groups in the trial
- Estradiol groupExisting treatment, for comparison
received oral estradiol valerate (Cycloprogynova) 4 mg/day during the luteal phase from day 21 To day2 preceding ovarian stimulation cycle
Treatment: GnRH Antagonist Protocol and Estradiol Valerate 4mg
- Control groupPlacebo, for comparison
women in the control group underwent standard GnRH antagonist stimulation without estradiol pretreatment
Treatment: GnRH Antagonist Protocol
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- 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
- Record updated
- 27 July 2026