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Single Injection of Ganirelix in Gonadotropin Intrauterine Insemination (IUI) Cycles

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ghassan F. Haddad, Houston Fertility Institute
ClinicalTrials.gov Identifier:
NCT01286051
First received: January 25, 2011
Last updated: March 19, 2013
Last verified: March 2013
  Purpose

Ovulation induction (OI) using gonadotropins is one of the most widely prescribed treatments of infertility. One common problem encountered while attempting OI using gonadotropins is premature ovulation. The purpose of this study is to examine the effect of a single injection of a medication, called ganirelix, to prevent premature ovulation. Patients will be divided into two groups. In the first group, gonadotropins will be used to stimulate the ovaries. In the second group gonadotropins will be used in addition to a single injection of ganirelix, a gonadotropin releasing hormone (GnRH) antagonist. Pregnancy rates will be compared between groups.


Condition Intervention
Compare Pregnancy Rates Between FSH Stimulation and FSH and
GnRH Antagonist
Drug: Follistim administration
Drug: Follistim plus Ganirelix

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Efficacy of Single Dose Ganirelix in Gonadotropin Ovulation Induction Cycles

Resource links provided by NLM:


Further study details as provided by Houston Fertility Institute:

Primary Outcome Measures:
  • Pregnancy rates [ Time Frame: One cycle of controlled ovarian stimulation (one month) ] [ Designated as safety issue: No ]
    Follicle stimulating hormone (FSH) and IUI


Secondary Outcome Measures:
  • Premature leuteinizing hormone (LH) surge and ovulation [ Time Frame: One cycle of controlled ovarian stimulation (one month) ] [ Designated as safety issue: No ]
    pregnancy rate in one cycle of FSH and single injection of GnRH antagonist


Enrollment: 80
Study Start Date: January 2011
Study Completion Date: September 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Follistim
standard treatment
Drug: Follistim administration
adminstation of FSH for ovulation induction
Other Name: Follistim
Experimental: Follistim plus single ganirelix injection Drug: Follistim plus Ganirelix
Follistim plus single injection of ganirelix
Other Names:
  • Follistim
  • ganirelix

Detailed Description:

A randomized prospective study will be performed on patients attempting pregnancy using ovulation induction/intra-uterine insemination (IUI). Patients will be randomly assigned to one of two protocols:

Protocol A (control group): On menstrual cycle day 3, the patient will start gonadotropins (Follistim) injections at a starting dose of 75-150 IU and monitored according to the discretion of the treating physician. When the leading follicle reaches a size of at least 18mm, intramuscular human chorionic gonadotripin (hCG) (10,000 IU) is administered, followed by two inseminations, one at 12 hours after hCG, and the other at 36 hours. All patients will have luteal support using progesterone vaginal suppositories at a dose of 200mg two times per day (BID). Pregnancy testing will be scheduled at 2 weeks after the IUI. The treatment cycle typically lasts from 8-13 days, depending on the patient's response.

Protocol B (study group): On menstrual cycle day 3, the patient will start gonadotropins (Follistim) injections at a starting dose of 75-150 IU and monitored according to the discretion of the treating physician. When the leading follicle reaches a size of 13-14mm in mean diameter, or when the estradiol level reaches a level of 400 pg/ml, ganirelix injection at the standard dose of 250mcg is given once subcutaneously. When the leading follicle reaches a size of at least 18mm, intramuscular hCG (10,000IU) is administered followed by two inseminations, one at 12 hours after hCG, and the other at 36 hours. All patients will have luteal support using progesterone suppositories at a dose of 200mg BID. Pregnancy testing will be scheduled at 2 weeks after the IUI. The treatment cycle typically lasts from 8-13 days, depending on the patient's response.

Patients will be randomized, via computer generated program, in a 1:1 fashion.

  Eligibility

Ages Eligible for Study:   18 Years to 39 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Patients undergoing ovulation induction (OI) between ages 18 - 39 years.
  • One or more of the following infertility diagnoses: ovulation dysfunction, mild male factor infertility (sperm concentration of 5- 20 million/ml, and/or sperm motility 10% - 40%) , absence teratospermia (i.e. strict morphology > 4%), unexplained infertility.
  • Patent Fallopian tubes.
  • Normal uterine structure (i.e. absence of mullerian anomalies)
  • Ability to consent to the study.
  • Patients should be Houston Fertility Institute patients

Exclusion Criteria:

Exclusion criteria include:

  • Age 39 or above
  • Severe male factor (concentration < 10 million/ml or strict morphology < 4%)
  • Obstructed Fallopian tubes on one or both sides
  • Stage III or IV endometriosis
  • Elevated FSH level (>10 IU/L)
  • Low antral follicular count (< 4 antral follicles per ovary)
  • Any other contraindication for ovulation induction
  • Inability to consent to the study
  • History of any prior failed OI/IUI cycle
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01286051

Locations
United States, Texas
Houston Fertility Institute
Houston, Texas, United States, 77063
Sponsors and Collaborators
Houston Fertility Institute
Investigators
Principal Investigator: Ghassan F Haddad, M.D. Houston Fertility Institute
  More Information

Additional Information:
No publications provided

Responsible Party: Ghassan F. Haddad, Medical Director, Houston Fertility Institute
ClinicalTrials.gov Identifier: NCT01286051     History of Changes
Other Study ID Numbers: P08115
Study First Received: January 25, 2011
Last Updated: March 19, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Houston Fertility Institute:
ovulation induction, GnRH

Additional relevant MeSH terms:
Ganirelix
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 20, 2014