GnRH Agonist Plus Hormone Replacement Therapy vs Hormone Replacement Therapy on IVF Outcomes

Phase 3

Completed

• Conditions: Polycystic Ovary Syndrome; Infertility, Female
• Interventions: Drug: HRT; Drug: Long GnRH agonist + HRT

• Registration Number: NCT05189873
• Lead Sponsor: Tehran University of Medical Sciences

Brief Summary

The study is conducted at Arash Women's Hospital on all women undergoing the frozen embryo transfer cycle. Patients who signed informed consent will be randomly divided into two groups. The first group will receive GnRH agonist plus hormone replacement therapy for endometrial preparation. Group 2 will receive hormone replacement therapy. The random allocation and final outcome of the study will be assessed by a person who is unaware of the study process. Also, the statistician will be unaware of the study process

Detailed Description

Not available

Study Timeline

• Study Start: 2021-06-10
• Status Verified: 2021-12
• Study First Submitted: 2021-12-11
• Primary Completion: 2022-01-03
• Study Completion: 2022-01-03
• Study First Submitted QC: 2022-01-12
• Last Update Submitted: 2022-01-12
• Study First Posted: 2022-01-13
• Last Update Posted: 2022-01-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 128

Inclusion Criteria

The first or second cycle of embryo transfer Normal uterine cavity PCO diagnosis based on Rotterdam criteria and correction (2018) Age 20 to 40 years

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Exclusion Criteria

Infertility with severe male factor endometriosis immunological disease FSH higher than 10 BMI greater than or equal to 30 Endometrial thickness on the day of transfer is less than 7 mm History of recurrent miscarriage

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
HRT	HRT	HRT protocol : estradiol and progesterone
Long GnRH agonist + HRT	Long GnRH agonist + HRT	Long GnRH agonist + HRT protocol: Superfect and estradiol and progesterone

Primary Outcome Measures

Name	Time	Method
Chemical pregnancy	14 days after transfer	A positive beta hCG levels
Clinical pregnancy	12 weeks of pregnancy	The gestational sac will be observed by Ultrasonography
Endometrial thickness	On the day of transfer	Endometrial thickness on the day of transfer will be measured by transvaginal ultrasound

Trial Locations

Locations (1)

Arash women's hospital,Tehran university of medical sciences; 🇮🇷 Tehran, Iran, Islamic Republic of