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

Sponsor
Houston Fertility Institute (Other)
Overall Status
Completed
CT.gov ID
NCT01286051
Collaborator
(none)
80
Enrollment
1
Location
2
Arms
20
Duration (Months)
4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 or Disease Intervention/Treatment Phase
  • Drug: Follistim administration
  • Drug: Follistim plus Ganirelix
 N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
80 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Efficacy of Single Dose Ganirelix in Gonadotropin Ovulation Induction Cycles
Study Start Date :
Jan 1, 2011
Actual Primary Completion Date :
Sep 1, 2012
Actual Study Completion Date :
Sep 1, 2012

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Follistim

standard treatment

Drug: Follistim administration
adminstation of FSH for ovulation induction
Other Names:
  • Follistim

    		•
    Experimental: Follistim plus single ganirelix injection

    Drug: Follistim plus Ganirelix
    Follistim plus single injection of ganirelix
    Other Names:
  • Follistim
  • ganirelix

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Pregnancy rates [One cycle of controlled ovarian stimulation (one month)]

      Follicle stimulating hormone (FSH) and IUI

    Secondary Outcome Measures

    1. Premature leuteinizing hormone (LH) surge and ovulation [One cycle of controlled ovarian stimulation (one month)]

      pregnancy rate in one cycle of FSH and single injection of GnRH antagonist

    Eligibility Criteria

    Criteria

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

    Locations

    Site City State Country Postal Code
    1 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

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Ghassan F. Haddad, Medical Director, Houston Fertility Institute
    ClinicalTrials.gov Identifier:
    NCT01286051
    Other Study ID Numbers:
    • P08115
    First Posted:
    Jan 31, 2011
    Last Update Posted:
    Mar 20, 2013
    Last Verified:
    Mar 1, 2013
    Keywords provided by Ghassan F. Haddad, Medical Director, Houston Fertility Institute
    ovulation induction, GnRH
    Additional relevant MeSH terms:
    Ganirelix

    Study Results

    No Results Posted as of Mar 20, 2013