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

December 15, 2016 updated by: Weill Medical College of Cornell University

Randomized Prospective Controlled Non-inferiority Trial of Low-dose Clomiphene Based Antagonist Protocol vs. High Dose Gonadotropin/Antagonist Protocol for IVF Poor Responders

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 42 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: High dose gonadotropins
High dose gonadotropins protocol compared to Low-dose Clomiphene
Drug: High 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
Other Names:
  • Gonal F or Follistim
Experimental: Low-dose Clomiphene
clomid-based, low dose gonadotropin protocol compared to High dose gonadotropins
Drug: Low-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
Other Names:
  • clomiphene citrate with low dose gonadotropins

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The number of mature oocytes retrieved
Time Frame: 1 year
To evaluate the number of mature oocytes retrieved in two different IVF protocols for poor responders
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The number of embryos transferred
Time Frame: 1year
To evaluate the number of embryos transferred
1year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Weill Medical College of Cornell University

Investigators

  • Principal Investigator: Owen Davis, MD, WCMC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2012

Primary Completion (Anticipated)

December 1, 2012

Study Completion (Anticipated)

December 1, 2012

Study Registration Dates

First Submitted

April 11, 2012

First Submitted That Met QC Criteria

April 11, 2012

First Posted (Estimate)

April 13, 2012

Study Record Updates

Last Update Posted (Estimate)

December 16, 2016

Last Update Submitted That Met QC Criteria

December 15, 2016

Last Verified

December 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1112012095

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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