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OpenTrials
Completed

NCT Number: NCT07727863

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

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.

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Key information

Age range

20 year–37 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Cairo University

Cairo, Cairo Governorate, 12111, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

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.

Treatment and study plan

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.

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

Primary outcomes

  1. Follicular synchronization

    Time frame: at day 8 of stimulation

    Mean follicle diameter and within patient standard deviation

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jul 27, 2026
Registry last updated
Jul 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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