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

NCT00830492 | Completed Phase 4 DMC

• 1 other identifier: YazdRCCI1388
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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

Keywords

clomiphene citrate; GnRH agonist; GnRH antagonist; in vitro fertilization; clinical pregnancy; pregnancy

Outcome Measures

Primary Outcomes (2)

• clinical pregnancy rate

  2 weeks

• ovarian stimulation safety

  3weeks

Study Arms (2)

2

ACTIVE COMPARATOR

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; Drug: buserelin; Drug: rFSH

clomiphen/gonadotropin/GnRH antagonist

EXPERIMENTAL

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; Procedure: Ultrasound; Drug: GnRH antagonist; Drug: gonadotopin (HMG)

Interventions

clomiphene citrate DRUG

100 mg from cycle day 3 through 7

clomiphen/gonadotropin/GnRH antagonist

Ultrasound PROCEDURE

cycle day 8

2; clomiphen/gonadotropin/GnRH antagonist

GnRH antagonist DRUG

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

clomiphen/gonadotropin/GnRH antagonist

gonadotopin (HMG) DRUG

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

clomiphen/gonadotropin/GnRH antagonist

buserelin 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.

2

rFSH DRUG

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

2

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• patient requiring ICSI

Sponsors & Collaborators

• Yazd Research & Clinical Center for Infertility: lead

Study Sites (1)

Yazd Research and Clinical Center For Infertility

Yazd, Yazd Province, Iran

Location

MeSH Terms

Interventions

Clomiphene; High-Energy Shock Waves; LHRH, Ac-Nal(1)-Cpa(2)-Trp(3)-Arg(6)-Ala(10)-; Buserelin

Intervention Hierarchy (Ancestors)

Stilbenes; Benzylidene Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Ultrasonic Waves; Sound; Radiation, Nonionizing; Radiation; Physical Phenomena; Gonadotropin-Releasing Hormone; Pituitary Hormone-Releasing Hormones; Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 27, 2009
• First Posted: January 28, 2009
• Study Start: January 1, 2008
• Primary Completion: December 1, 2008
• Study Completion: December 1, 2008
• Last Updated: January 28, 2009

Record last verified: 2009-01

Locations

IR (1)