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

NCT01286051 | Completed

• 1 other identifier: P08115
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

ovulation induction, GnRH

Outcome Measures

Primary Outcomes (1)

• Pregnancy rates

  Follicle stimulating hormone (FSH) and IUI

  One cycle of controlled ovarian stimulation (one month)

Secondary Outcomes (1)

• Premature leuteinizing hormone (LH) surge and ovulation

  One cycle of controlled ovarian stimulation (one month)

Study Arms (2)

Follistim

ACTIVE COMPARATOR

standard treatment

Drug: Follistim administration

Follistim plus single ganirelix injection

EXPERIMENTAL

Drug: Follistim plus Ganirelix

Interventions

Follistim administration DRUG

adminstation of FSH for ovulation induction

Also known as: Follistim

Follistim

Follistim plus Ganirelix DRUG

Follistim plus single injection of ganirelix

Also known as: Follistim, ganirelix

Follistim plus single ganirelix injection

Eligibility Criteria

• Age: 18 Years - 39 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Houston Fertility Institute: lead

Study Sites (1)

Houston Fertility Institute

Houston, Texas, 77063, United States

Location

Related Links

• practice website

MeSH Terms

Interventions

follitropin beta; ganirelix

Study Officials

• Ghassan F Haddad, M.D.

  Houston Fertility Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Director

Study Record Dates

• First Submitted: January 25, 2011
• First Posted: January 31, 2011
• Study Start: January 1, 2011
• Primary Completion: September 1, 2012
• Study Completion: September 1, 2012
• Last Updated: March 20, 2013

Record last verified: 2013-03

Locations

US (1)