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

Phase 4

Withdrawn

• Conditions: Infertility
• Interventions: Drug: High dose gonadotropins; Drug: Low-dose Clomiphene

• Registration Number: NCT01577199
• Lead Sponsor: Weill Medical College of Cornell University

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.

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study Start: 2012-04
• Study First Submitted: 2012-04-11
• Study First Submitted QC: 2012-04-11
• Study First Posted: 2012-04-13
• Primary Completion: 2012-12
• Study Completion: 2012-12
• Status Verified: 2016-12
• Last Update Submitted: 2016-12-15
• Last Update Posted: 2016-12-16

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Female
• Target Recruitment: Not specified

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
High dose gonadotropins	High dose gonadotropins	High dose gonadotropins protocol compared to Low-dose Clomiphene
Low-dose Clomiphene	Low-dose Clomiphene	clomid-based, low dose gonadotropin protocol compared to High dose gonadotropins

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
The number of embryos transferred	1year	To evaluate the number of embryos transferred