NCT05189873

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 128 (actual)
• Sponsor: Tehran University of Medical Sciences · Academic / Other
• Sex: Female
• Age: 20 Years – 40 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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
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

Timeline

• Start date: 2021-06-10
• Primary completion: 2022-01-03
• Completion: 2022-01-03
• First posted: 2022-01-13
• Last updated: 2022-01-13

Locations

1 site across 1 country: Iran