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

This study has been completed.
Sponsor:
Information provided by:
Yazd Research & Clinical Center for Infertility
ClinicalTrials.gov Identifier:
NCT00830492
First received: January 27, 2009
Last updated: NA
Last verified: January 2009
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Ovarian Stimulation
Drug: clomiphene citrate
Procedure: Ultrasound
Drug: GnRH antagonist
Drug: gonadotopin (HMG)
Drug: buserelin
Drug: rFSH
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: Comparisin CC/Gonadotropin/GnRH Antagonist and Gonadotropin/GnRH Agonist in IVF Outcome.

Resource links provided by NLM:


Further study details as provided by Yazd Research & Clinical Center for Infertility:

Primary Outcome Measures:
  • clinical pregnancy rate [ Time Frame: 2 weeks ] [ Designated as safety issue: Yes ]
  • ovarian stimulation safety [ Time Frame: 3weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 200
Study Start Date: January 2008
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
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).
Drug: gonadotopin (HMG)
75 IU human menopausal gonadotropin (Menogon, ferring, pharmacenticals , Germany)

  Eligibility

Ages Eligible for Study:   18 Years to 35 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00830492

Locations
Iran, Islamic Republic of
Yazd Research and Clinical Center For Infertility
Yazd, Iran, Islamic Republic of
Sponsors and Collaborators
Yazd Research & Clinical Center for Infertility
  More Information

No publications provided

Responsible Party: Mohammad Ali karimzadeh, yazd research and clinical center for IVF
ClinicalTrials.gov Identifier: NCT00830492     History of Changes
Other Study ID Numbers: YazdRCCI1388
Study First Received: January 27, 2009
Last Updated: January 27, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by Yazd Research & Clinical Center for Infertility:
clomiphene citrate
GnRH agonist
GnRH antagonist
in vitro fertilization
clinical pregnancy
pregnancy

Additional relevant MeSH terms:
Buserelin
Clomiphene
Citric Acid
Deslorelin
Fertility Agents, Female
Fertility Agents
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Anticoagulants
Hematologic Agents
Chelating Agents
Molecular Mechanisms of Pharmacological Action
Estrogen Antagonists
Estrogen Receptor Modulators
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Selective Estrogen Receptor Modulators
Enzyme Inhibitors

ClinicalTrials.gov processed this record on July 28, 2014