Luteal Phase FSH in the IVF Poor Responder
| Status: | Completed |
|---|---|
| Conditions: | Women's Studies, Infertility |
| Therapuetic Areas: | Reproductive |
| Healthy: | No |
| Age Range: | 20 - 42 |
| Updated: | 4/21/2016 |
| Start Date: | September 2005 |
| End Date: | June 2008 |
Luteal Phase Recombinant FSH vs. Follicular Phase Recombinant FSH for IVF Stimulation in the Poor Responder
In vitro fertilization (IVF) is a common procedure used to assist couples who have
difficulty conceiving a pregnancy. IVF is a process where oocytes (eggs) are retrieved from
a woman's ovaries and fertilized with sperm in the laboratory. In order to maximize the
number of oocytes that can be retrieved, a women undergoes ovarian stimulation with
recombinant follicle stimulating hormone (FSH). Typically 6-20 oocytes are retrieved, but in
some cases there is a limited response to the stimulation, producing a limited number of
oocytes. This is called poor ovarian response.
This study is designed to objectively compare two treatment regimens currently advocated in
clinical practice, but never compared directly. The purpose is to assess ovarian response to
starting treatment at the end of the preceding cycle may increase the number of developing
oocytes.
difficulty conceiving a pregnancy. IVF is a process where oocytes (eggs) are retrieved from
a woman's ovaries and fertilized with sperm in the laboratory. In order to maximize the
number of oocytes that can be retrieved, a women undergoes ovarian stimulation with
recombinant follicle stimulating hormone (FSH). Typically 6-20 oocytes are retrieved, but in
some cases there is a limited response to the stimulation, producing a limited number of
oocytes. This is called poor ovarian response.
This study is designed to objectively compare two treatment regimens currently advocated in
clinical practice, but never compared directly. The purpose is to assess ovarian response to
starting treatment at the end of the preceding cycle may increase the number of developing
oocytes.
Inclusion Criteria:
1. Infertile women planning to undergo IVF
2. Poor ovarian response in most-recent previous IVF cycle within the past 18 months as
defined by the following criteria:
A) <5 dominant follicles day of hCG, B) <5 oocytes retrieved, or C) cancellation of a
previous IVF cycle due to poor response to ovulation stimulation.
3. Aged 20-42 (inclusive) at the time of randomization
4. Presence of both ovaries
5. Normal pap smear within past three years
6. At least 45 days after the last IVF cycle
7. Be willing and able to comply with the protocol for the duration of the study
8. Have given written informed consent, prior to any study-related procedure, not part
of normal medical care, with the understanding that consent may be withdrawn by the
patient at any time without prejudice to their future medical care.
Exclusion Criteria:
1. Clinically significant systemic disease
2. Current regular cigarette smoking by patient report
3. Known to be positive for Human Immunodeficiency Virus
4. Any medical condition which, in the judgment of the investigator and sponsor, may
interfere with the absorption, distribution, metabolism or excretion of the
medications used
5. Abnormal, undiagnosed gynecological bleeding
6. Known allergy or hypersensitivity to human gonadotropin preparations
7. Simultaneous participation in another investigational drug or device trial
8. Subject fails, in 2 separate menstrual cycle attempts, to have FSH ≤12.0 and an
ultrasound exam within normal limits (per standard for IVF) at the Baseline Visit
9. For subjects randomized to the Luteal Phase Regimen, failure to ovulate in 2 separate
menstrual cycle attempts, as evidenced by ovulation predictor kit, progesterone
level, and /or visualization of corpus luteum cyst on an ovary by ultrasound exam at
the Luteal Visit
We found this trial at
1
site
Click here to add this to my saved trials
