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

IVF Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05167838
• Other study ID #: Cairo University obgyn
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2022
• Est. completion date: July 1, 2022

Study information

• Verified date: April 2022
• Source: Cairo University
• Contact: Marwa Mo Eid, Ass.prof
• Phone: 01001225079
• Email: marwameid2014[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 110
• Est. completion date: July 1, 2022
• Est. primary completion date: June 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• IVF

Intervention

Procedure:
• fresh embryo transfer
55 patients undergoing fresh embryo transfer after ovarian stimulation followed by luteal phase support
• Frozen embryo transfer
55 patients undergoing frozen embryo transfer after ovarian stimulation followed by cryopreservation of all embryos and transfer in another cycle.

Locations

Country	Name	City	State
Egypt	Marwa Eid	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical pregnancy rate	Transvaginal Ultrasound to detect gestational sac(GS)	35 days after embryo transfer
Secondary	Chemical pregnancy rate	Serum ß-human chorionic gonadotropin (HCG) will be measured to determine pregnancy after embryo transfer.	14 days after embryo transfer.
Secondary	Early ovarian hyperstimulation syndrome rate(OHSS rate)	Abdominal ultrasound ,Hematocrit	3 days after follicular aspiration
Secondary	Ectopic pregnancy rate	BHCG then doubling after 48 hours ,vaginal ultrasound	14 days for BHCG , vaginal US 3 weeks after transfer