Comparative Study Between Fresh and Frozen Embryo Transfer in PCOS Patients Undergoing IVF Treatment
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
1 other identifier
interventional
110
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jan 2022
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 23, 2021
CompletedFirst Posted
Study publicly available on registry
December 22, 2021
CompletedStudy Start
First participant enrolled
January 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2022
CompletedApril 12, 2022
April 1, 2022
5 months
November 23, 2021
April 11, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Clinical pregnancy rate
Transvaginal Ultrasound to detect gestational sac(GS)
35 days after embryo transfer
Secondary Outcomes (3)
Chemical pregnancy rate
14 days after embryo transfer.
Early ovarian hyperstimulation syndrome rate(OHSS rate)
3 days after follicular aspiration
Ectopic pregnancy rate
14 days for BHCG , vaginal US 3 weeks after transfer
Study Arms (2)
group A
EXPERIMENTALFresh embryo transfer group
Group B
EXPERIMENTALFrozen embryo transfer group
Interventions
55 patients undergoing fresh embryo transfer after ovarian stimulation followed by luteal phase support
55 patients undergoing frozen embryo transfer after ovarian stimulation followed by cryopreservation of all embryos and transfer in another cycle.
Eligibility Criteria
You may qualify if:
- 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).
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cairo Universitylead
Study Sites (1)
Marwa Eid
Cairo, Egypt
Study Officials
- PRINCIPAL INVESTIGATOR
Marwa Mo Eid, MD
Cairo U
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal investigator
Study Record Dates
First Submitted
November 23, 2021
First Posted
December 22, 2021
Study Start
January 1, 2022
Primary Completion
June 1, 2022
Study Completion
July 1, 2022
Last Updated
April 12, 2022
Record last verified: 2022-04