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

Study Overview
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Brief Summary
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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

Official Title
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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

Conditions
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Polycystic Ovary Syndrome, Infertility, Female

Intervention / Treatment
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* Drug: Long GnRH agonist + HRT
* Drug: HRT


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HRT<br>HRT protocol : estradiol and progesterone | Drug: HRT<br>* 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<br>|
| Experimental: Long GnRH agonist + HRT<br>Long GnRH agonist + HRT protocol: Superfect and estradiol and progesterone | Drug: Long GnRH agonist + HRT<br>* 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<br>|

What is the study measuring?
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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 |