Comparative Study Between Fresh and Frozen Embryo Transfer in PCOS Patients Undergoing IVF Treatment

Study Overview
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Brief Summary
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The objective of our study is to compare in vitro fertilization (IVF) outcomes between fresh embryo transfer (ET) and frozen-thawed ET in women with polycystic ovary syndrome (PCOS).

Detailed Description
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Eligible women will be randomized to two groups in a ratio of 1:1 . Both the patients and the clinicians will be aware of the allocated arm. The patients (110) will be equally randomized into two groups: Group A will undergo a day 3 fresh embryo transfer after ovarian stimulation, luteal phase support will be started just after follicular aspiration. Group B will have all of their embryo cryopreserved after ovarian stimulation with no luteal phase support after the aspiration and then undergo a frozen-thawed day 3 embryo transfer. Controlled ovarian stimulation will be done using the gonadotropin releasing hormone (GnRH) antagonist protocol then human chorionic gonadotropin( HCG) 5000 IU trigger for final oocyte maturation.

Official Title
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A Comparative Study Between Fresh and Frozen Embryo Transfer in Cases of Polycystic Ovaries Syndrome (PCOS) Patients Undergoing in Vitro Fertilization (IVF) Treatment for Infertility as Regards Clinical Pregnancy Rate and IVF Outcome

Conditions
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IVF

Intervention / Treatment
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* Procedure: fresh embryo transfer
* Procedure: Frozen embryo transfer


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women diagnosed with PCOS according to modified Rotterdam criteria which includes menstrual abnormalities combined with either hyperandrogenism (hirsutism diagnosed by modified Ferriman-Gallwey score or elevated total testosterone level) or polycystic ovaries. Women ages ≥20 and <40years old. BMI less than 35. Women who have a history of infertility. All patients will receive adjuvant drugs for ovulation induction (metformin from preceding cycle, cabergoline 1 tab daily for 8 days and 500 cc colloid solution on day of ovum pick up). Exclusion Criteria: History of unilateral oophorectomy. Uterine abnormalities such as a malformed uterus (unicornuate, septate uterus), adenomyosis, submucous myoma or intrauterine adhesion. Severe male factor for infertility such as azoospermia. History of repeated ICSI trials failure. Women who are unable to comply with the study procedures.

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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Accepts Healthy Volunteers

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
Interventional Model Description: Group 1; Fresh embryo transfer in PCO patients Group 2: Frozen ET in PCO patients
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: group A<br>Fresh embryo transfer group | Procedure: fresh embryo transfer<br>* 55 patients undergoing fresh embryo transfer after ovarian stimulation followed by luteal phase support<br>|
| Experimental: Group B<br>Frozen embryo transfer group | Procedure: Frozen embryo transfer<br>* 55 patients undergoing frozen embryo transfer after ovarian stimulation followed by cryopreservation of all embryos and transfer in another cycle.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical pregnancy rate | Transvaginal Ultrasound to detect gestational sac(GS) | 35 days after embryo transfer | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Chemical pregnancy rate | Serum β-human chorionic gonadotropin (HCG) will be measured to determine pregnancy after embryo transfer. | 14 days after embryo transfer. | 
| Early ovarian hyperstimulation syndrome rate(OHSS rate) | Abdominal ultrasound ,Hematocrit | 3 days after follicular aspiration | 
| Ectopic pregnancy rate | BHCG then doubling after 48 hours ,vaginal ultrasound | 14 days for BHCG , vaginal US 3 weeks after transfer | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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IVF-Fresh ET-FET-clinical pregnancy