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Completed

NCT Number: NCT00830492

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.

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Key information

Conditions

OVARIAN STIMULATION

Age range

18 year–35 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Yazd Research and Clinical Center For Infertility

Yazd, Yazd Province, Iran

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Clomiphene Citrate

Drug

100 mg from cycle day 3 through 7

Ultrasound

Procedure

cycle day 8

GnRh antagonist

Drug

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

gonadotopin (HMG)

Drug

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

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.

rFSH

Drug

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

Primary outcomes

  1. clinical pregnancy rate

    Time frame: 2 weeks

  2. ovarian stimulation safety

    Time frame: 3weeks

Sponsors and collaborators

Lead sponsor

Yazd Research & Clinical Center for Infertility

Other

Registry information

Official study title

Comparisin CC/Gonadotropin/GnRH Antagonist and Gonadotropin/GnRH Agonist in IVF Outcome.

Important dates

Study start
2008
Primary completion
2008
Study completion
2008
First posted
Jan 28, 2009
Registry last updated
Jan 28, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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