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

NCT01577199 | Withdrawn Phase 4

• 1 other identifier: 1112012095
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Infertility

Keywords

IVF; poor responder; low ovarian reserve; ART; ovarian stimulation; IVF protocols

Outcome Measures

Primary Outcomes (1)

• The number of mature oocytes retrieved

  To evaluate the number of mature oocytes retrieved in two different IVF protocols for poor responders

  1 year

Secondary Outcomes (1)

• The number of embryos transferred

  1year

Study Arms (2)

High dose gonadotropins

ACTIVE COMPARATOR

High dose gonadotropins protocol compared to Low-dose Clomiphene

Drug: High dose gonadotropins

Low-dose Clomiphene

EXPERIMENTAL

clomid-based, low dose gonadotropin protocol compared to High dose gonadotropins

Drug: Low-dose Clomiphene

Interventions

Low-dose Clomiphene DRUG

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

Also known as: clomiphene citrate with low dose gonadotropins

Low-dose Clomiphene

High dose gonadotropins DRUG

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

Also known as: Gonal F or Follistim

High dose gonadotropins

Eligibility Criteria

• Age: 18 Years - 42 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patients age 18-42 undergoing IVF
• AFC \<7 (see definition above) and AMH (see definition above) \<0.5 and/or prior poor IVF response

You may not qualify if:

• 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

Sponsors & Collaborators

• Weill Medical College of Cornell University: lead

Related Links

• Center for Reproductive Medicine

MeSH Terms

Conditions

Infertility

Interventions

Clomiphene; Gonadotropins; follitropin alfa; follitropin beta

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Stilbenes; Benzylidene Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• Owen Davis, MD

  WCMC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 11, 2012
• First Posted: April 13, 2012
• Study Start: April 1, 2012
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: December 16, 2016

Record last verified: 2016-12

Data Sharing

• IPD Sharing: Will not share