Clomiphene Citrate (CC)/Gonadotropin/Gonadotropin Releasing Hormone (GnRH) Antagonist Versus Gonadotropin/GnRH Agonist
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.
Drug: clomiphene citrate
Drug: GnRH antagonist
Drug: gonadotopin (HMG)
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
|Official Title:||Comparisin CC/Gonadotropin/GnRH Antagonist and Gonadotropin/GnRH Agonist in IVF Outcome.|
- clinical pregnancy rate [ Time Frame: 2 weeks ] [ Designated as safety issue: Yes ]
- ovarian stimulation safety [ Time Frame: 3weeks ] [ Designated as safety issue: Yes ]
|Study Start Date:||January 2008|
|Study Completion Date:||December 2008|
|Primary Completion Date:||December 2008 (Final data collection date for primary outcome measure)|
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 8Drug: buserelin
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.Drug: rFSH
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 7Procedure: Ultrasound
cycle day 8Drug: 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)
Please refer to this study by its ClinicalTrials.gov identifier: NCT00830492
|Iran, Islamic Republic of|
|Yazd Research and Clinical Center For Infertility|
|Yazd, Iran, Islamic Republic of|