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

Ovarian Stimulation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00830492
• Other study ID #: YazdRCCI1388
• Status: Completed
• Phase: Phase 4
• First received: January 27, 2009
• Last updated: January 27, 2009
• Start date: January 2008
• Est. completion date: December 2008

Study information

• Verified date: January 2009
• Source: Yazd Research & Clinical Center for Infertility
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: December 2008
• Est. primary completion date: December 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 35 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Ovarian Stimulation

Intervention

Drug:
• clomiphene citrate
100 mg from cycle day 3 through 7

Procedure:
• Ultrasound
cycle day 8

Drug:
• GnRH antagonist
Daily, started with dominant follicle greater than 14 mm (Ganirelix , Organon, Netherlands).
• gonadotopin (HMG)
75 IU human menopausal gonadotropin (Menogon, ferring, pharmacenticals , Germany)
• 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.
• rFSH
150-225 IU recombinant FSH (r_FSH) (Gonal F, Serono, Aubnne, Switzerland) S.C.

Locations

Country	Name	City	State
Iran, Islamic Republic of	Yazd Research and Clinical Center For Infertility	Yazd

Sponsors (1)

Lead Sponsor	Collaborator
Yazd Research & Clinical Center for Infertility

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	clinical pregnancy rate		2 weeks	Yes
Primary	ovarian stimulation safety		3weeks	Yes