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

Cairo University (CU)

Status: Unknown

Conditions: IVF

Treatments: Procedure: fresh embryo transfer; Procedure: Frozen embryo transfer

Study type: Interventional

Funder types: Other

Identifiers

NCT05167838

Cairo University obgyn

Details and patient eligibility

About

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).

Full 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.

Enrollment: 110 estimated patients

Sex: Female

Ages: 20 to 40 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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110 participants in 2 patient groups

group A

Experimental group

Description:

Fresh embryo transfer group

Treatment:

Procedure: fresh embryo transfer

Group B

Experimental group

Description:

Frozen embryo transfer group

Treatment:

Procedure: Frozen embryo transfer