Clomiphene Citrate (CC)/Gonadotropin/Gonadotropin Releasing Hormone (GnRH) Antagonist Versus Gonadotropin/GnRH Agonist

Study Overview
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Brief Summary
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Objective: To compare the efficacy of using mild ovarian stimulation protocol and conventional stimulation protocol in IVF outcome. Design: Prospective randomized trial Setting: University IVF setting. Patient(s): The study compromised a total 200 subinfertile couple that women had regulary menstruation. Intervention(s): Patients were randomized to treatment clomiphene citrate, gonadotropin and GnRH antagonist (100 patients) or GnRH agonist and gonadotropin ( 100 patients). Main outcome measure: Clinical pregnancy rate. Key Words: clomiphene citrate, GnRH agonist, GnRH antagonist, in vitro fertilization, pregnancy rate.

Official Title
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Comparisin CC/Gonadotropin/GnRH Antagonist and Gonadotropin/GnRH Agonist in IVF Outcome.

Conditions
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Ovarian Stimulation

Intervention / Treatment
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* Drug: clomiphene citrate
* Procedure: Ultrasound
* Drug: GnRH antagonist
* Drug: gonadotopin (HMG)
* Drug: buserelin
* Drug: rFSH


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: female patient age 18-35 years, presence of a regular and proven ovulatory menstruation cycle with a length of 26-35 days basal FSH <10 IU/L and body mass index (BMI) of 18-30 (kg/m²) Indication for IVF were unexplained infertility, mild male factor, tubal factor, early stage endometriosis and cervical factor Exclusion Criteria: patient requiring ICSI

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 2<br>In group A (n=100), the patients were stimulated conventional. They desensitized with buserelin (suprefact, Aventis, Frankfurt, Germany) 500µg subcutaneously (S.C.) everyday for menstrual cycle 21, until the baseline evaluation, which takes place in the first few days of menstruation. If baseline levels of estradiol (<50 pg/ml ) had been achieved, then the dose of buserelin would be reduced to 250µg and ovarian stimulation would commence with 150-225 IU recombinant FSH (r_FSH) (Gonal F, Serono, Aubnne, Switzerland) S.C. | Procedure: Ultrasound<br>* cycle day 8<br>Drug: buserelin<br>* Buserelin (suprefact, Aventis, Frankfurt, Germany) 500µg subcutaneously (S.C.) everyday for menstrual cycle 21, until the baseline evaluation, which takes place in the first few days of menstruation. If baseline levels of estradiol (<50 pg/ml ) had been achieved, then the dose of buserelin would be reduced to 250µg.<br>Drug: rFSH<br>* 150-225 IU recombinant FSH (r_FSH) (Gonal F, Serono, Aubnne, Switzerland) S.C.<br>|
| Experimental: clomiphen/gonadotropin/GnRH antagonist<br>Patients in group B ( n=100 ) were stimulated clomiphene citrate ( ) 100 mg from cycle day three through seven and continuous gonadotropin stimulation with of r_FSH 75 IU daily from cycle day 5. Ultrasound in two group was performed on 8 cycle day. In group B 0.25 mg GnRH antagonist (Ganirelix , Organon ,Netherland ) daily was started with dominant follicle ≥14mm and in this day 75 IU human menopoasl gonadotropin (HMG) (Menogon, ferring, pharmacenticals , Germany ) increased to the initial gonadotropin . LH assessment on the day of starting antagonist was performed and if LH was >15 IU/L , cycle was cancelled. Human chorionic gonadotropin 10000 IU ((pregnyl, Organon, Oss, the Netherlands ) was given when 1 to 3 follicles reached 18 mm | Drug: clomiphene citrate<br>* 100 mg from cycle day 3 through 7<br>Procedure: Ultrasound<br>* cycle day 8<br>Drug: GnRH antagonist<br>* Daily, started with dominant follicle greater than 14 mm (Ganirelix , Organon, Netherlands).<br>Drug: gonadotopin (HMG)<br>* 75 IU human menopausal gonadotropin (Menogon, ferring, pharmacenticals , Germany)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| clinical pregnancy rate |  | 2 weeks | 
| ovarian stimulation safety |  | 3weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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clomiphene citrate, GnRH agonist, GnRH antagonist, in vitro fertilization, clinical pregnancy, pregnancy