Clomiphene Citrate (CC)/Gonadotropin/Gonadotropin Releasing Hormone (GnRH) Antagonist Versus Gonadotropin/GnRH Agonist
|ClinicalTrials.gov Identifier: NCT00830492|
Recruitment Status : Completed
First Posted : January 28, 2009
Last Update Posted : January 28, 2009
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.
|Condition or disease||Intervention/treatment||Phase|
|Ovarian Stimulation||Drug: clomiphene citrate Procedure: Ultrasound Drug: GnRH antagonist Drug: gonadotopin (HMG) Drug: buserelin Drug: rFSH||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||200 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Comparisin CC/Gonadotropin/GnRH Antagonist and Gonadotropin/GnRH Agonist in IVF Outcome.|
|Study Start Date :||January 2008|
|Actual Primary Completion Date :||December 2008|
|Actual Study Completion Date :||December 2008|
Active Comparator: 2
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.
cycle day 8
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.
150-225 IU recombinant FSH (r_FSH) (Gonal F, Serono, Aubnne, Switzerland) S.C.
Experimental: clomiphen/gonadotropin/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
Drug: clomiphene citrate
100 mg from cycle day 3 through 7
cycle day 8
Drug: GnRH antagonist
Daily, started with dominant follicle greater than 14 mm (Ganirelix , Organon, Netherlands).
Drug: gonadotopin (HMG)
75 IU human menopausal gonadotropin (Menogon, ferring, pharmacenticals , Germany)
- clinical pregnancy rate [ Time Frame: 2 weeks ]
- ovarian stimulation safety [ Time Frame: 3weeks ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00830492
|Iran, Islamic Republic of|
|Yazd Research and Clinical Center For Infertility|
|Yazd, Iran, Islamic Republic of|