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

NCT ID: NCT00830492

Last Updated: 2009-01-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-01-31
• Study Completion Date: 2008-12-31

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.

Conditions

Ovarian Stimulation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Ultrasound

Intervention Type: PROCEDURE

cycle day 8

buserelin

Intervention Type: DRUG

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.

rFSH

Intervention Type: DRUG

150-225 IU recombinant FSH (r\_FSH) (Gonal F, Serono, Aubnne, Switzerland) S.C.

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

Group Type: EXPERIMENTAL

clomiphene citrate

Intervention Type: DRUG

100 mg from cycle day 3 through 7

Ultrasound

Intervention Type: PROCEDURE

cycle day 8

GnRH antagonist

Intervention Type: DRUG

Daily, started with dominant follicle greater than 14 mm (Ganirelix , Organon, Netherlands).

gonadotopin (HMG)

Intervention Type: DRUG

75 IU human menopausal gonadotropin (Menogon, ferring, pharmacenticals , Germany)

Interventions

clomiphene citrate

100 mg from cycle day 3 through 7

Intervention Type: DRUG

Ultrasound

cycle day 8

Intervention Type: PROCEDURE

GnRH antagonist

Daily, started with dominant follicle greater than 14 mm (Ganirelix , Organon, Netherlands).

Intervention Type: DRUG

gonadotopin (HMG)

75 IU human menopausal gonadotropin (Menogon, ferring, pharmacenticals , Germany)

Intervention Type: DRUG

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.

Intervention Type: DRUG

rFSH

150-225 IU recombinant FSH (r\_FSH) (Gonal F, Serono, Aubnne, Switzerland) S.C.

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Yazd Research & Clinical Center for Infertility

OTHER

Sponsor Role: lead

Responsible Party

yazd research and clinical center for IVF

Locations

Yazd Research and Clinical Center For Infertility

Yazd, Yazd Province, Iran

Countries

Iran

Other Identifiers

YazdRCCI1388

Identifier Type: -

Identifier Source: org_study_id