Comparison Between Effects of Dydrogesterone, Cetrorelix Acetate and Triptorelin on Intra Cytoplasmic Sperm Injection Outcomes
Trial Snapshot
- Phase
- Phase 3
- Status
- Recruiting
- Sponsor
- Beni-Suef University
- Enrollment
- 387
- Locations
- 1
- Primary Endpoint
- Number of oocytes retrieved.
Study Overview
Brief Summary
To compare the effects of Duphaston compared to GnRH agonist and antagonist on the prevention of premature LH surge and quality of retrieved oocytes and embryos in women undergoing intra-cytoplasmic sperm injection.
Detailed Description
Study Design:
A randomized clinical trial (RCT).
Study Site:
The study will be conducted at Beni-Suef University Hospital Assisted Reproductive Techniques center. The study population includes all infertile women undergoing IVF at Beni-Suef University ART center will be included. Women will be recruited for enrollment when they come to fertility clinic and scheduled for ICSI trial. They will be counseled and asked to participate in the study after been evaluated to ensure fulfilling inclusion and exclusion criteria.
Study Sample:
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 20 Years to 40 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Having indications for ICSI.
Exclusion Criteria
- •Any known contraindications to the approved fertility drugs.
- •Severe endometriosis.
- •Uterine malformations or abnormal uterine cavity.
- •Uncontrolled endocrinopathies: DM, hyperthyroidism, hypothyroidism.
- •Severe male factor for infertility.
Arms & Interventions
Dydrogesterone
For pituitary suppression, the patients receives Dydrogesterone (Duphaston 10 mg/twice daily, Abbott Healthcare, America) orally since day 2-3.
Intervention: Dydrogesterone (Drug)
GnRH antagonist
For pituitary suppression, the patients receives GnRH antagonist (CETROTIDE 0.25MG , MERCK SERONO, Germany) 0.25 mg/day subcutaneously since the dominant follicles reached the diameter of 12-14 mm till trigger day.
Intervention: Cetrorelix acetate (Drug)
GnRH agonist
For pituitary suppression, the patients receives (Decapeptyl, sc 0.1 mg/day) beginning in the afternoon of the 21st day of the cycle prior to stimulation
Intervention: Triptorelin (Drug)
Outcomes
Primary Outcomes
Number of oocytes retrieved.
Time Frame: 1cycle (1 month)
number of oocytes
maturity of oocytes retrieved.
Time Frame: 1 cycle (1month)
either M2 or M1
Secondary Outcomes
- Duration of stimulation(1 ICSI cycle (1 month))
Investigators
Sara Abdallah Mohamed Salem
Lecturer of Gynecology and obstetrics Faculty of medicine Beni-Suef University
Beni-Suef University