Clinical trial NCT05167838: Comparative Study Between Fresh and Frozen Embryo Transfer in PCOS Patients Undergoing IVF Treatment
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: IVF
Keywords: IVF-Fresh ET-FET-clinical pregnancy
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2021-12-22
Enrollment: 110
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Group 1; Fresh embryo transfer in PCO patients Group 2: Frozen ET in PCO patients
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Clinical pregnancy rate
timeFrame: 35 days after embryo transfer
Secondary outcomes:
measure: Chemical pregnancy rate
timeFrame: 14 days after embryo transfer.
measure: Early ovarian hyperstimulation syndrome rate(OHSS rate)
timeFrame: 3 days after follicular aspiration
measure: Ectopic pregnancy rate
timeFrame: 14 days for BHCG , vaginal US 3 weeks after transfer
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Marwa Eid
Study officials:
affiliation: Cairo U
name: Marwa Mo Eid, MD
role: PRINCIPAL_INVESTIGATOR
References: