Single Injection of Ganirelix in Gonadotropin Intrauterine Insemination (IUI) Cycles
| Status: | Completed |
|---|---|
| Conditions: | Women's Studies |
| Therapuetic Areas: | Reproductive |
| Healthy: | No |
| Age Range: | 18 - 39 |
| Updated: | 10/14/2017 |
| Start Date: | January 2011 |
| End Date: | September 2012 |
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.
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.
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.
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
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