Comparing different hormone triggers for oocyte maturation in women at risk of OHSS
Dual Trigger Versus Gonadotropin Releasing Hormone Agonist Trigger Combined With Luteal Human Chorionic Gonadotropin Administration
This study is testing which hormone trigger helps women at risk of ovarian hyperstimulation syndrome have better egg development and fertility during a specific fertility treatment.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 225 (estimated) |
| Ages | 20 Years to 35 Years |
| Sex | Female |
| Sponsor | Mansoura University Academic / other |
| Locations | 2 sites (Mansourah, Dakahlia and 1 other locations) |
| Trial ID | NCT02330770 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to compare reproductive outcomes in women undergoing intracytoplasmic sperm injection (ICSI) who are at risk for ovarian hyperstimulation syndrome (OHSS). Participants will be randomized into three groups: one receiving a dual trigger of GnRHa and low-dose HCG, another receiving a single low-dose HCG, and the last receiving multiple low-doses of HCG. The study will utilize a GnRH antagonist protocol for controlled ovarian hyperstimulation and monitor follicular growth through transvaginal sonography. The goal is to determine which triggering method yields the best outcomes for oocyte maturation and subsequent fertility.
Who should consider this trial
Good fit: Ideal candidates include women undergoing ICSI with a risk of OHSS due to factors like previous OHSS, PCOS, or high antral follicle counts.
Not a fit: Patients who are outside the age range of 20 to 35 years or have conditions like severe endometriosis or uterine abnormalities may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve reproductive outcomes for women at risk of OHSS during fertility treatments.
How similar studies have performed: Other studies have shown promising results with similar hormone triggering approaches, indicating potential for success in this trial.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Women subjected to ICSI through controlled ovarian hyperstimulation (COH) with pituitary downregulation by GnRH antagonist. * Presence of risk for development of OHSS: 1) previous moderate or severe OHSS; 2) PCOS or polycystic ovary on ultrasound scan; 3) antral follicle count (AFC) \> 14 in both ovaries; 4) basal serum AMH level \> 3.36 ng/ml; 5) \> 14 follicles with diameter of ≥ 11 mm on the day of triggering of oocyte maturation; 6) E2 level \> 3000 pg/ml on the day of triggering of oocyte maturation. Exclusion Criteria: * Age \< 20 years or \> 35 years. * BMI \< 19 kg/m2 or \> 35 kg/m2. * Moderate or severe endometriosis. * Hydrosalpinx. * Uterine abnormalities or myoma. * Previous uterine surgery. * Use of alternative techniques to minimize the risk of OHSS.
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.