Antagonist Protocol in Poor Responders
Phase 4
Completed
- Conditions
- Female Infertility Due to Diminished Ovarian Reserve
- Interventions
- Registration Number
- NCT02195947
- Lead Sponsor
- Cairo University
- Brief Summary
The effect of use of the growth hormone with antagonist protocol on the outcome of the IVF/ICSI cycles in poor responders.
- Detailed Description
Two groups of poor responder female patients planned to receive the antagonist IVF/ICSI protocol are randomized to whether or not to add growth hormone to their protocol.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 141
Inclusion Criteria
- females fulfilling the criteria of the ESHRE consensus 2011:
- at least two of the following three features must be present:
- dvanced maternal age (≥40 years) or any other risk factor for POR
- previous POR (≤3 oocytes with a conventional stimulation protocol)
- an abnormal ovarian reserve test (i.e. AFC ,5-7 follicles or AMH ,0.5 -1.1 ng/ml).
Exclusion Criteria
- women who suffer from any other cause of infertility other than poor ovarian reserve
- refusal of the patient to consent for using her data in the study.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Antagonist and Growth hormone Growth Hormone HMG IM daily was administrated from day 2 of the cycle. The GnRH antagonist (Cetrotide, Serono, Geneva, Switzerland) was given when the leading follicle was from 12 to 14 mm, at a daily dose of 0.25 mg SC. Growth hormone (Norditropin, Novo nordisk) was administrated on day 6 of HMG stimulation daily in a dose of 2.5 mg S.C. till the day of hCG administration.
- Primary Outcome Measures
Name Time Method Live birth rate Up to 9 months
- Secondary Outcome Measures
Name Time Method Clinical pregnancy rate Up to 5 weeks
Trial Locations
- Locations (1)
Kasr Al Aini
🇪🇬Cairo, Egypt