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

Efficacy of Single Dose Ganirelix in Gonadotropin Ovulation Induction Cycles

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.

Study Overview

• Status: Completed
• Conditions: GnRH Antagonist; Compare Pregnancy Rates Between FSH Stimulation and FSH and
• Intervention / Treatment: Drug: Follistim administration; Drug: Follistim plus 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.

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77063
      • Houston Fertility Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 39 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pregnancy rates	Follicle stimulating hormone (FSH) and IUI	One cycle of controlled ovarian stimulation (one month)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Premature leuteinizing hormone (LH) surge and ovulation	pregnancy rate in one cycle of FSH and single injection of GnRH antagonist	One cycle of controlled ovarian stimulation (one month)

Collaborators and Investigators

• Sponsor: Houston Fertility Institute
• Investigators: Principal Investigator: Ghassan F Haddad, M.D., Houston Fertility Institute

Publications and helpful links

Helpful Links

• practice website

Study record dates

Study Major Dates

• Study Start: January 1, 2011
• Primary Completion (Actual): September 1, 2012
• Study Completion (Actual): September 1, 2012

Study Registration Dates

• First Submitted: January 25, 2011
• First Submitted That Met QC Criteria: January 27, 2011
• First Posted (Estimate): January 31, 2011

Study Record Updates

• Last Update Posted (Estimate): March 20, 2013
• Last Update Submitted That Met QC Criteria: March 19, 2013
• Last Verified: March 1, 2013

More Information

Terms related to this study

• Keywords: ovulation induction, GnRH
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Hormones, Hormone Substitutes, and Hormone Antagonists; Hormone Antagonists; Ganirelix
• Other Study ID Numbers: P08115