Clomiphene Citrate (CC)/Gonadotropin/Gonadotropin Releasing Hormone (GnRH) Antagonist Versus Gonadotropin/GnRH Agonist
Phase 4
Completed
- Conditions
- Ovarian Stimulation
- Interventions
- Procedure: UltrasoundDrug: rFSHDrug: gonadotopin (HMG)
- Registration Number
- NCT00830492
- Lead Sponsor
- Yazd Research & Clinical Center for Infertility
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 200
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 2 Ultrasound 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. 2 rFSH 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. clomiphen/gonadotropin/GnRH antagonist Ultrasound 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 clomiphen/gonadotropin/GnRH antagonist gonadotopin (HMG) 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 clomiphen/gonadotropin/GnRH antagonist GnRH antagonist 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 clomiphen/gonadotropin/GnRH antagonist clomiphene citrate 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 2 buserelin 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.
- Primary Outcome Measures
Name Time Method ovarian stimulation safety 3weeks clinical pregnancy rate 2 weeks
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Yazd Research and Clinical Center For Infertility
🇮🇷Yazd, Iran, Islamic Republic of