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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Follistim | Active Comparator | standard treatment |
|
| Follistim plus single ganirelix injection | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Follistim administration | Drug | adminstation of FSH for ovulation induction |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pregnancy rates | Follicle stimulating hormone (FSH) and IUI | One cycle of controlled ovarian stimulation (one month) |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
Exclusion criteria include:
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| Name | Affiliation | Role |
|---|---|---|
| Ghassan F Haddad, M.D. | Houston Fertility Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Houston Fertility Institute | Houston | Texas | 77063 | United States |
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| Label | URL |
|---|---|
| practice website | View source |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Feb 24, 2014 | |
| Reset | Apr 3, 2014 | |
| Release | Apr 3, 2014 | |
| Reset | May 2, 2014 | |
| Release | Apr 23, 2015 | |
| Reset | Apr 23, 2015 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Feb 24, 2014 | Apr 3, 2014 | |||
| Apr 3, 2014 |
| ID | Term |
|---|---|
| C571802 | follitropin beta |
| C061018 | ganirelix |
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| Follistim plus Ganirelix | Drug | Follistim plus single injection of ganirelix |
|
|
| May 2, 2014 |
| Apr 23, 2015 | Apr 23, 2015 |