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

GnRH Antagonist Clinical Trial

Official title:

Efficacy of Single Dose Ganirelix in Gonadotropin Ovulation Induction Cycles

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01286051
• Other study ID #: P08115
• Status: Completed
• Phase: N/A
• First received: January 25, 2011
• Last updated: March 19, 2013
• Start date: January 2011
• Est. completion date: September 2012

Study information

• Verified date: March 2013
• Source: Houston Fertility Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: September 2012
• Est. primary completion date: September 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 39 Years

Eligibility

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

Related Conditions & MeSH terms

• Compare Pregnancy Rates Between FSH Stimulation and FSH and
• GnRH Antagonist

Intervention

Drug:
• Follistim administration
adminstation of FSH for ovulation induction
• Follistim plus Ganirelix
Follistim plus single injection of ganirelix

Locations

Country	Name	City	State
United States	Houston Fertility Institute	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Houston Fertility Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pregnancy rates	Follicle stimulating hormone (FSH) and IUI	One cycle of controlled ovarian stimulation (one month)
Secondary	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)

External Links

•   practice website