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

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

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.

Study Overview

• Status: Completed
• Conditions: Ovarian Stimulation
• Intervention / Treatment: Procedure: Ultrasound; Drug: buserelin; Drug: rFSH; Drug: clomiphene citrate; Drug: GnRH antagonist; Drug: gonadotopin (HMG)

• Study Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Phase 4

Contacts and Locations

Study Locations

• Iran, Islamic Republic of
  • Yazd, Iran, Islamic Republic of
    • Yazd Research and Clinical Center For Infertility

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 35 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Procedure: Ultrasound; cycle day 8; 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.; 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	Procedure: Ultrasound; cycle day 8; Drug: clomiphene citrate; 100 mg from cycle day 3 through 7; 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
clinical pregnancy rate	2 weeks
ovarian stimulation safety	3weeks

Collaborators and Investigators

• Sponsor: Yazd Research & Clinical Center for Infertility

Study record dates

Study Major Dates

• Study Start: January 1, 2008
• Primary Completion (ACTUAL): December 1, 2008
• Study Completion (ACTUAL): December 1, 2008

Study Registration Dates

• First Submitted: January 27, 2009
• First Submitted That Met QC Criteria: January 27, 2009
• First Posted (ESTIMATE): January 28, 2009

Study Record Updates

• Last Update Posted (ESTIMATE): January 28, 2009
• Last Update Submitted That Met QC Criteria: January 27, 2009
• Last Verified: January 1, 2009

More Information

Terms related to this study

• Keywords: pregnancy; GnRH agonist; in vitro fertilization; GnRH antagonist; clomiphene citrate; clinical pregnancy
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Hormones, Hormone Substitutes, and Hormone Antagonists; Hormone Antagonists; Estrogen Antagonists; Reproductive Control Agents; Fertility Agents, Female; Fertility Agents; Selective Estrogen Receptor Modulators; Estrogen Receptor Modulators; Clomiphene; Enclomiphene; Zuclomiphene; Buserelin
• Other Study ID Numbers: YazdRCCI1388