Clinical trial NCT01577199: RCT of Low-dose Clomiphene vs. High Dose Gonadotropin Protocol for IVF Poor Responders
Official title: Randomized Prospective Controlled Non-inferiority Trial of Low-dose Clomiphene Based Antagonist Protocol vs. High Dose Gonadotropin/Antagonist Protocol for IVF Poor Responders
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Infertility
Keywords: IVF
poor responder
low ovarian reserve
ART
ovarian stimulation
IVF protocols
Lead sponsor: Weill Medical College of Cornell University
Sponsor class: OTHER
First posted: 2012-04-13
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 42
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: The number of mature oocytes retrieved
timeFrame: 1 year
Secondary outcomes:
measure: The number of embryos transferred
timeFrame: 1year
Other outcomes:
Locations:
Study officials:
affiliation: WCMC
name: Owen Davis, MD
role: PRINCIPAL_INVESTIGATOR
References: