Triggering of Final Oocyte Maturation With GnRHa (Buserelin) in GnRH Antagonist Cycles

Study Overview
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Brief Summary
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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

Official Title
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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)

Conditions
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OHSS (Ovarian Hyperstimulation)

Intervention / Treatment
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* Drug: Buserelin and Pregnyl
* Drug: Pregnyl
* Drug: Buserelin and Pregnyl
* Drug: Pregnyl


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 39 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br>More than 14 follicles with a diameter of > 11mm: triggering of ovulation with 0.5 mg GnRHa (Buserelin) (s.c.) + 1500 IU hCG (Pregnyl) | Drug: Buserelin and Pregnyl<br>* Subcutaneous injection 0.5 mg and 1500 IU<br>|
| Active Comparator: B<br>More than 14 follicles with a diameter of > 11mm: triggering of ovulation with hCG (Pregnyl) 5.000 IU (s.c.) | Drug: Pregnyl<br>* Subcutaneous injection 5000 IU<br>|
| Experimental: C<br>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) | Drug: Buserelin and Pregnyl<br>* Subcutaneous injection 0,5 mg and 1500 IU + 1500 IU after 7 days<br>|
| Active Comparator: D<br>14 or less follicles with a diameter of > 11mm: triggering of ovulation with 5000 IU hCG (Pregnyl) (s.c.) | Drug: Pregnyl<br>* Subcutaneous injection 5000 IU<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of Moderate to Severe OHSS. |  | From the date of triggering ovulation until 2 weeks after pregnancy test. group C and D. 12 days after pregnancy test | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pregnancy Rate |  | from stimulation day 1 until last ultrasound scan 7 weeks after a positive pregnancy test | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hCG, GnRH antagonist, GnRH agonist, OHSS, In vitro fertilization, ovulation induction, Clinical pregnancy rate