Infertility
Conditions
Keywords
IVF, poor responder, low ovarian reserve, ART, ovarian stimulation, IVF protocols
Brief summary
The purpose of this study is compare two commonly-used medication protocols ( low-dose clomiphene citrate and high dose gonadotropin protocols) for the treatment of patients with diminished ovarian reserve (decreased number of eggs remaining in the ovary) undergoing IVF. This research is being done because we do not know if these two medication protocols are equally likely to help a woman become pregnant.
Detailed description
The objective of this protocol is to prospectively evaluate whether a clomid-based, low dose gonadotropin protocol (225 IU) would be non-inferior in terms of mature oocyte yield (eggs that are ready to be fertilized) as compared to a high-dose protocol. Patients meeting the criteria for poor ovarian response will be consented and randomized to either a stimulation protocol involving pretreatment with a 0.1mg estradiol patch in the luteal phase starting 10 days after the LH surge (the hormone released by the brain to cause ovulation to occur, which is detectable in urine) followed by oral clomiphene citrate 100mg on days 2-6 of the menstrual cycle and 225 international units of gonadotropins starting on day 5, or to the control group involving the same pretreatment with 0.1mg luteal estradiol patches starting 10 days after the LH surge, with high dose gonadotropins (600IU) alone, starting on day 2 of the cycle. After randomization, patients will undergo routine IVF procedures, monitoring, blood draws, cancellation criteria, oocyte retrieval, and embryo transfer as non-study participants.
Interventions
DRUGLow-dose Clomiphene
Pretreatment with a 0.1mg estradiol patch in the luteal phase starting 10 days after the LH surge followed by clomiphene citrate 100mgon days 2-6 of the menstrual cycle with 225 international units of gonadotropins (eg Follistim , Menopur) starting on day 5
DRUGHigh dose gonadotropins
Pretreatment with a 0.1mg estradiol patch in the luteal phase starting 10 days after the LH surge followed high dose gonadotropins (eg. Follistim. Menopur) 600IU starting on day 2 of the cycle
Sponsors
Weill Medical College of Cornell University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 42 Years
Healthy volunteers
No
Inclusion criteria
* Patients age 18-42 undergoing IVF * AFC \<7 (see definition above) and AMH (see definition above) \<0.5 and/or prior poor IVF response
Exclusion criteria
* BMI (body mass index) \>30 * PGD (preimplantation genetic diagnosis, in which embryos are biopsied to rule out chromosomal abnormalities) * Age \>42 * Fragile X carriers (a condition associated with premature ovarian aging) * TESE (Testicular sperm extraction) * Asherman's syndrome (uterine scarring which can affect implantation and pregnancy) * Untreated hydrosalpinx (accumulated fluid in the fallopian tube which may be toxic to embryos) * \>6 prior attempted cycles
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The number of mature oocytes retrieved | 1 year | To evaluate the number of mature oocytes retrieved in two different IVF protocols for poor responders |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The number of embryos transferred | 1year | To evaluate the number of embryos transferred |
Outcome results
None listed