Mild Versus Conventional Ovarian Stimulation for Poor Responders Undergoing In Vitro Fertilisation
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- number of oocytes (COCs)
Study Overview
Brief Summary
The investigators will examine the balance between IVF success in terms of outcome parameters, using a mild ovarian stimulation protocol, opposing it to the conventional stimulation regimens in poor responders undergoing IVF.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 25 Years to 45 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •poor responders (age>40, previous POR, abnormal OR test)
- •indication for IVF
- •regular cycling patients
- •BMI 19-35
Exclusion Criteria
- •contraindication for clomiphene citrate use or to GnRH agonists antagonists
- •BMI > 35
Arms & Interventions
mild ovarian stimulation
100 mg CC by day 2 till 6, plus antagonist plus gonadotrophin 150-200IO until HCG triggering
Intervention: mild ovarian stimulation (Procedure)
conventional ovarian stimulation
300-450 IU of FSH starting by day 2 of menstrual cycle together with a fixed dose of GnRH antagonist starting by day 6 till egg recovery, or same doses using a GnRH agonist long protocol
Intervention: conventional ovarian stimulation (Procedure)
Outcomes
Primary Outcomes
number of oocytes (COCs)
Time Frame: at oocyte recovery
Secondary Outcomes
- Number/rate of participants whom the IVF cycle was cancelled(After the 1st week of ovarian stimulation, no oocytes at OR)
- clinical pregnancy rate(6 weeks)
- cancellation rate(from start of stimulation until ET)
- live birth(more than 20 weeks)
- miscarriage(pregnancy loss before 20 weeks of gestation, after a positive pregnancy test)
- stimulation characteristics(from start of stimulation until embryo transfer)
Investigators
Siristatidis Charalampos, MD, PhD
Assistant Professor, Director of the ARU
National and Kapodistrian University of Athens