Comparing hormone therapy and ovarian stimulation for preparing the uterus before embryo transfer
Hormone Replacement Therapy Versus Minimal Ovarian Stimulation for Endometrial Preparation Prior to Frozen-thawed Embryo Transfer in Non Polycystic Ovarian Syndrome Patients
PHASE4 · Mansoura University · NCT02330757
This study is testing whether hormone therapy or a mild ovarian stimulation method works better to prepare the uterus for women having a frozen embryo transfer.
Quick facts
| Phase | PHASE4 |
|---|---|
| Study type | Interventional |
| Enrollment | 150 (estimated) |
| Ages | 20 Years to 38 Years |
| Sex | Female |
| Sponsor | Mansoura University (other) |
| Locations | 2 sites (Mansourah, Dakahlia and 1 other locations) |
| Trial ID | NCT02330757 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates two methods of endometrial preparation prior to frozen-thawed embryo transfer (FET) in women without polycystic ovarian syndrome (PCOS). Participants will be randomly assigned to receive either hormone replacement therapy (HRT) with estradiol valerate or minimal ovarian stimulation (MOS) using clomiphene citrate and gonadotropins. The effectiveness of each method will be assessed by measuring endometrial thickness and quality before proceeding with embryo transfer. The study aims to determine which approach leads to better outcomes in infertility treatment.
Who should consider this trial
Good fit: Ideal candidates for this study are women without PCOS who have at least two cryopreserved good quality embryos.
Not a fit: Patients with PCOS, moderate to severe endometriosis, or uterine abnormalities may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve the success rates of embryo transfers in women without PCOS.
How similar studies have performed: Other studies have shown varying success with similar approaches, but this specific comparison of HRT versus MOS in non-PCOS patients is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Women without PCOS as defined by the Rotterdam criteria. * Presence of at least 2 cryopreserved good quality cleavage-stage embryo (good quality cleavage-stage embryos display stage-specific cell division, have blastomeres of fairly equal size with few to no cytoplasmic fragments). Exclusion Criteria: * PCOS or polycystic ovary on ultrasound scan. * Moderate or severe endometriosis. * Hydrosalpinx. * Uterine abnormalities or myoma. * Previous uterine surgery.
Where this trial is running
Mansourah, Dakahlia and 1 other locations
- Fertility Care Unit (FCU) in Mansoura University Hospital — Mansourah, Dakahlia, Egypt (RECRUITING)
- Private fertility care centers — Mansourah, Dakahlia, Egypt (RECRUITING)
Study contacts
- Principal investigator: Mohamed S Abdelhafez, Dr — Mansoura University
- Study coordinator: Mohamed S Abdelhafez, Dr
- Email: msabdelhafez@gmail.com
- Phone: +201144523366
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Infertility, Frozen-thawed embryo transfer, FET protocols