Among ICSI Patients Undergoing Antagonist Protocols With Recombinant FSH, Does Replacement of Recombinant FSH by 200 IU of hCG in the Late Follicular Phase Compared With Continuing Recombinant FSH, Result in a Similar Number of Oocytes?
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Enrollment
- 70
- Locations
- 1
- Primary Endpoint
- Number of oocytes in both treatment groups
Study Overview
Brief Summary
In this study,the investigators compared two protocols for controlled ovarian hyperstimulation in infertility patients requiring IVF. In the control group, the patient undergoes a standard antagonist protocol. In the study group, the administration of gonadotropins is stopped in the late follicular phase and replaced by low dose human chorionic gonadotropins. The primary endpoint of the study is the number of oocytes retrieved in both groups.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Investigator)
Eligibility Criteria
- Ages
- 18 Years to 36 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •< 36 years on day of randomisation
- •FSH < 12 in the early follicular phase
- •Normal ultrasound scan
- •BMI between 18 and 29 (both inclusive)
- •Randomisation at outpatient clinic
Exclusion Criteria
- •Endometriosis ≥ grade 3
- •PCO syndrome
- •Poor responder
- •Endocrine or metabolic abnormalities
Arms & Interventions
A
Patients undergo a standard antagonist protocol for in-vitro fertilisation, and are stimulated with recombinant gonadotropins.
Intervention: recombinant gonadotropins (Drug)
B
Patients are undergo an antagonist protocol for in-vitro fertilisation and are stimulated with recombinant gonadotropins. When the patient has an estradiol value of 600 ng/L or more and when the patient has at least 6 follicles of 12 mm, the administration of gonadotropins is stopped and replaced by low dose human chorionic gonadotropins.
Intervention: human chorionic gonadotropin (Drug)
Outcomes
Primary Outcomes
Number of oocytes in both treatment groups
Time Frame: up to 9 months
Secondary Outcomes
- Duration of stimulation in both treatment groups, amount of gonadotropins consumed in each treatment group(up to 9 months)