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

Tehran University of Medical Sciences

Status and phase: Completed; Phase 3

Conditions: Polycystic Ovary Syndrome; Infertility, Female

Treatments: Drug: HRT; Drug: Long GnRH agonist + HRT

Study type: Interventional

Funder types: Other

Identifiers

NCT05189873

99-3-101-51284

Details and patient eligibility

About

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

Enrollment: 128 patients

Sex: Female

Ages: 20 to 40 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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128 participants in 2 patient groups

HRT

Experimental group

Description:

HRT protocol : estradiol and progesterone

Treatment:

Drug: HRT

Long GnRH agonist + HRT

Experimental group

Description:

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

Treatment:

Drug: Long GnRH agonist + HRT