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Effect of Estradiol Pretreatment on Follicular Synchronization and IVF Outcomes in Women With Polycystic Ovary Syndrome Undergoing ICSI Using GnRH Antagonist Protocol

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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07727863
Enrollment
61
Registered
2026-07-27
Start date
2024-09-13
Completion date
2026-06-21
Last updated
2026-07-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

IVF Outcomes, PCOS GnRH Antagonist and GnRH Agonist IVF/ICSI Cycles

Brief 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 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.

Interventions

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.

oral estradiol valerate (Cycloprogynova) 4 mg/day during the luteal phase from day 21 To day 2 preceding ovarian stimulation cycle

Sponsors

Cairo University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
20 Years to 37 Years
Healthy volunteers
No

Inclusion criteria

* PCOS was defined by the presence of at least two of the following: 1. oligo or anovulation, 2. clinical or biochemical hyperandrogenism, and 3. 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.

Exclusion criteria

* 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.

Design outcomes

Primary

MeasureTime frameDescription
Follicular synchronizationat day 8 of stimulationMean follicle diameter and within patient standard deviation

Countries

Egypt

Contacts

PRINCIPAL_INVESTIGATORAhmed Maged

Cairo University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 28, 2026