A Prospective Randomised Study to Evaluate the Effect of Triggering Ovulation With GnRHa (Buserelin) and Low Dose hCG (Pregnyl) as Compared to the Use of Conventional Doses of hCG (Pregnyl)
Overview
- Phase
- Phase 4
- Intervention
- Buserelin and Pregnyl
- Conditions
- OHSS (Ovarian Hyperstimulation)
- Sponsor
- Regionshospitalet Viborg, Skive
- Enrollment
- 384
- Locations
- 1
- Primary Endpoint
- Frequency of Moderate to Severe OHSS.
- Status
- Completed
- Last Updated
- 12 years ago
Overview
Brief Summary
The purpose of this study is to possibly further improve the clinical outcome and explore the incidence of OHSS in patients, who have final oocyte maturation with GnRHa (Buserelin) in GnRH antagonist IVF/ICSI cycles
Investigators
Peter Humaidan
Prof. M.D. D.M.Sc.
Regionshospitalet Viborg, Skive
Eligibility Criteria
Inclusion Criteria
- •Patient complying with the conditions for IVF or ICSI treatment
- •Female age over 20 years and under 40 years
- •Normal regular cycle and patients with oligomenorrhea
- •BMI \> 18 and \< 35
- •each patient contributes with one cycle only
Exclusion Criteria
- •Significant disturbances in the woman (diabetes, epilepsy, liver/renal/heart disease, metabolic disorder)
- •Patients with \> 25 follicles on the day of triggering ovulation
Arms & Interventions
A
More than 14 follicles with a diameter of \> 11mm: triggering of ovulation with 0.5 mg GnRHa (Buserelin) (s.c.) + 1500 IU hCG (Pregnyl)
Intervention: Buserelin and Pregnyl
B
More than 14 follicles with a diameter of \> 11mm: triggering of ovulation with hCG (Pregnyl) 5.000 IU (s.c.)
Intervention: Pregnyl
C
14 or less follicles with a diameter of \> 11mm: triggering of ovulation with 0.5 mg GnRHa (Buserelin) (s.c.) + 1500 IU hCG (Pregnyl) (s.c.) at 35 hours and 1500 IU hCG (Pregnyl) (s.c.) 7 days after triggering of ovulation (OPU + 5)
Intervention: Buserelin and Pregnyl
D
14 or less follicles with a diameter of \> 11mm: triggering of ovulation with 5000 IU hCG (Pregnyl) (s.c.)
Intervention: Pregnyl
Outcomes
Primary Outcomes
Frequency of Moderate to Severe OHSS.
Time Frame: From the date of triggering ovulation until 2 weeks after pregnancy test. group C and D. 12 days after pregnancy test
Secondary Outcomes
- Pregnancy Rate(from stimulation day 1 until last ultrasound scan 7 weeks after a positive pregnancy test)