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

NCT05189873 | Completed Phase 3

• 1 other identifier: 99-3-101-51284
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 1

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

Conditions

Polycystic Ovary Syndrome; Infertility, Female

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (2)

HRT

EXPERIMENTAL

HRT protocol : estradiol and progesterone

Drug: HRT

Long GnRH agonist + HRT

EXPERIMENTAL

Long GnRH agonist + HRT protocol: Superfect and estradiol and progesterone

Drug: Long GnRH agonist + HRT

Interventions

Long GnRH agonist + HRT DRUG

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

Long GnRH agonist + HRT

HRT DRUG

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

HRT

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Tehran University of Medical Sciences: lead

Study Sites (1)

Arash women's hospital,Tehran university of medical sciences

Tehran, 1653915981, Iran

Location

MeSH Terms

Conditions

Polycystic Ovary Syndrome; Infertility, Female

Interventions

Hormone Replacement Therapy

Condition Hierarchy (Ancestors)

Ovarian Cysts; Cysts; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases; Infertility

Intervention Hierarchy (Ancestors)

Drug Therapy; Therapeutics

Study Officials

• Ashraf Moini, professor

  Tehran University of Medical Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The randomization list will be prepared by a statistician using the block randomization method (using the site:www.sealedenvelope.com). Treatments are placed in sealed envelopes and will be kept by the out-of-study nurse. After identification of the eligibility of the patient, the procedure is explained to her and informed consent is obtained. Then the treatment is performed based on the kind of treatment in the envelope.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 11, 2021
• First Posted: January 13, 2022
• Study Start: June 10, 2021
• Primary Completion: January 3, 2022
• Study Completion: January 3, 2022
• Last Updated: January 13, 2022

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

IR (1)