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

NCT07727863 | Completed DMC

• 1 other identifier: 369
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Follicular synchronization

  Mean follicle diameter and within patient standard deviation

  at day 8 of stimulation

Study Arms (2)

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

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

Drug: GnRH Antagonist Protocol

Interventions

GnRH Antagonist Protocol DRUG

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.

Control group; Estradiol group

Estradiol Valerate 4mg DRUG

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

Estradiol group

Eligibility Criteria

• Age: 20 Years - 37 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Cairo University

Cairo, Cairo Governorate, 12111, Egypt

Location

MeSH Terms

Interventions

Estradiol

Intervention Hierarchy (Ancestors)

Estrenes; Estranes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Estradiol Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• Ahmed Maged

  Cairo University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 16, 2026
• First Posted: July 27, 2026
• Study Start: September 13, 2024
• Primary Completion: February 17, 2026
• Study Completion: June 21, 2026
• Last Updated: July 27, 2026

Record last verified: 2026-07

Locations

EG (1)