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

Comparison of the Pregnancy Outcomes in Patients With the Polycystic Ovarian Syndrome in Two Endometrial Preparation Method GnRH Agonist Plus Hormone Replacement Therapy Versus Hormone Replacement Therapy in Frozen Embryo Transfer Cycle

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

Study Overview

• Status: Completed
• Conditions: Polycystic Ovary Syndrome; Infertility, Female
• Intervention / Treatment: Drug: HRT; Drug: Long GnRH agonist + HRT

• Study Type: Interventional
• Enrollment (Actual): 128
• Phase: Phase 3

Contacts and Locations

Study Locations

• Iran, Islamic Republic of
  • Tehran, Iran, Islamic Republic of, 1653915981
    • Arash women's hospital,Tehran university of medical sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: HRT; HRT protocol : estradiol and progesterone	Drug: HRT; In the HRT group, from the second day of the cycle, the participant receives 2 mg of estradiol daily and this drug is increased to 6 mg per day in three days.Ten days later, they undergo vaginal ultrasound to check the thickness of the endometrium. If the thickness of the endometrium is greater than 8 mm, inject able progesterone is prescribed and the patient is a candidate for FET transfer. If the thickness is less than 7 mm, it is necessary to increase the dose of estradiol and continue treatment with it. The patient undergoes vaginal ultrasound every three days and if the desired thickness does not reach 21 days after the start of the cycle, the cycle is canceled
Experimental: Long GnRH agonist + HRT; Long GnRH agonist + HRT protocol: Superfect and estradiol and progesterone	Drug: Long GnRH agonist + HRT; Intervention group:(Long GnRH agonist + HRT) From day 18-21 of the previous cycle, 0.5 cc of Superfect is injected daily and vaginal ultrasound is performed 10-14 days later If the endometrial thickness is less than 5 mm and there are no ovarian cysts, estradiol is started like HRT treatment and the agonist dose of GnRH starts with estradiol. It is halved (0.25 cc superfect) and superfect is prescribed until progesterone is started. At the time of progesterone administration, the administration of superfect is discontinued. Injections of estradiol and progesterone is the same as for the HRT group

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Tehran University of Medical Sciences
• Investigators: Principal Investigator: Ashraf Moini, professor, Tehran University of Medical Sciences

Study record dates

Study Major Dates

• Study Start (Actual): June 10, 2021
• Primary Completion (Actual): January 3, 2022
• Study Completion (Actual): January 3, 2022

Study Registration Dates

• First Submitted: December 11, 2021
• First Submitted That Met QC Criteria: January 12, 2022
• First Posted (Actual): January 13, 2022

Study Record Updates

• Last Update Posted (Actual): January 13, 2022
• Last Update Submitted That Met QC Criteria: January 12, 2022
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Endocrine System Diseases; Disease; Ovarian Cysts; Cysts; Ovarian Diseases; Adnexal Diseases; Gonadal Disorders; Polycystic Ovary Syndrome; Syndrome; Infertility; Infertility, Female
• Other Study ID Numbers: 99-3-101-51284

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: It is not yet known if there will be a plan to make this available

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No