Randomized Clinical Trial of Low-dose Clomiphene Based Antagonist Protocol vs. High Dose Gonadotropin/Antagonist Protocol for IVF Poor Responders (CLOVANT)

This study has suspended participant recruitment.
Sponsor:
Information provided by (Responsible Party):
Weill Medical College of Cornell University
ClinicalTrials.gov Identifier:
NCT01577199
First received: April 11, 2012
Last updated: December 13, 2012
Last verified: December 2012
  Purpose

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.


Condition Intervention Phase
Infertility
Drug: clomiphene citrate with low dose gonadotropins
Drug: Gonal F or Follistim
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Weill Medical College of Cornell University:

Primary Outcome Measures:
  • The number of mature oocytes retrieved [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    To evaluate the number of mature oocytes retrieved in two different IVF protocols for poor responders


Secondary Outcome Measures:
  • The number of embryos transferred [ Time Frame: 1year ] [ Designated as safety issue: No ]
    To evaluate the number of embryos transferred


Estimated Enrollment: 106
Study Start Date: April 2012
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: High dose gonadotropins
High dose gonadotropins protocol
Drug: Gonal F or Follistim
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
Experimental: Low-dose Clomiphene
clomid-based, low dose gonadotropin protocol
Drug: clomiphene citrate with low dose gonadotropins
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

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

Ages Eligible for Study:   18 Years to 42 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01577199

Sponsors and Collaborators
Weill Medical College of Cornell University
Investigators
Principal Investigator: Owen Davis, MD WCMC
  More Information

Additional Information:
No publications provided

Responsible Party: Weill Medical College of Cornell University
ClinicalTrials.gov Identifier: NCT01577199     History of Changes
Other Study ID Numbers: 1112012095
Study First Received: April 11, 2012
Last Updated: December 13, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Weill Medical College of Cornell University:
IVF
poor responder
low ovarian reserve
ART
ovarian stimulation
IVF protocols

Additional relevant MeSH terms:
Infertility
Genital Diseases, Male
Genital Diseases, Female
Clomiphene
Enclomiphene
Zuclomiphene
Estrogen Antagonists
Estrogen Receptor Modulators
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Fertility Agents, Female
Fertility Agents
Reproductive Control Agents
Therapeutic Uses
Selective Estrogen Receptor Modulators

ClinicalTrials.gov processed this record on September 16, 2014