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

Not Applicable

• Conditions: IVF
• Interventions: Procedure: Frozen embryo transfer; Procedure: fresh embryo transfer

• Registration Number: NCT05167838
• Lead Sponsor: Cairo University

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2021-11-23
• Study First Submitted QC: 2021-12-21
• Study First Posted: 2021-12-22
• Study Start: 2022-01-01
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-11
• Last Update Posted: 2022-04-12
• Primary Completion: 2022-06-01
• Study Completion: 2022-07-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 110

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group B	Frozen embryo transfer	Frozen embryo transfer group
group A	fresh embryo transfer	Fresh embryo transfer group

Primary Outcome Measures

Name	Time	Method
Clinical pregnancy rate	35 days after embryo transfer	Transvaginal Ultrasound to detect gestational sac(GS)

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Marwa Eid; 🇪🇬 Cairo, Egypt