Gonadotropin Releasing Hormone Agonist for Luteal Phase Support in Gonadotropin Releasing Hormone Antagonist Protocol Cycles
Overview
- Phase
- Phase 4
- Intervention
- Triptorelin
- Conditions
- Infertility
- Sponsor
- Mansoura University
- Enrollment
- 200
- Locations
- 2
- Primary Endpoint
- Clinical pregnancy rate
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
Evaluation of the effect of adding a single dose of gonadotropin releasing hormone agonist (GnRHa) as a luteal phase support on the outcomes of intracytoplasmic sperm injection (ICSI) following GnRH antagonist protocol
Detailed Description
Endometrial preparation for embryo transfer (ET) will be started after oocyte retrieval by giving 800 mg/day natural progesterone vaginal supplement + 4 mg/day estradiol oral supplement. The patients will be randomly divided into 2 groups for luteal phase support: (i) Group A (GnRHa group) in which the luteal phase support will be continued by the same regimen started on the day of oocytes retrieval until 2 weeks after embryo transfer (ET) with subcutaneous administration of a single dose (0.2 mg) of GnRHa (Triptorelin) 6 days after oocyte retrieval, and (ii) Group B (control group) in which the luteal phase support will be continued only by the same regimen started on the day of oocytes retrieval until 2 weeks after ET
Investigators
Mohamed Sayed Abdelhafez
Dr
Mansoura University
Eligibility Criteria
Inclusion Criteria
- •Women subjected to ICSI through controlled ovarian hyperstimulation (COH) with pituitary downregulation by GnRH antagonist.
Exclusion Criteria
- •Moderate or severe endometriosis.
- •Hydrosalpinx.
- •Uterine abnormalities.
- •Previous uterine surgery.
Arms & Interventions
GnRHa group
Luteal phase SC administration of a single dose (0.2 mg) of GnRHa (Triptorelin)
Intervention: Triptorelin
Outcomes
Primary Outcomes
Clinical pregnancy rate
Time Frame: 6 weeks after embryo transfer
Number of clinical pregnancies (defined as presence of at least one intrauterine gestational sac with fetal pole and cardiac activity on TVS scan at 4-6 weeks after the ET) divided by the number of ET procedures
Secondary Outcomes
- Miscarriage rate(12 weeks gestational age)
- Implantation rate(6 weeks after embryo transfer)