RCT of Low-dose Clomiphene vs. High Dose Gonadotropin Protocol for IVF Poor Responders

• Status: Withdrawn
• Trial end date: 2012-12-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Weill Medical College of Cornell University
• Treatments: Clomiphene; Enclomiphene; Zuclomiphene

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