Hormonal Stimulation in IUI Treatment: Is Clomifen Combined With Ethinyl Estradiol Better, Worse or Equal to Menopur

NCT01569945 | Completed

• 1 other identifier: ML2436 - 1
• Study Type: interventional
• Target: 371
• Locations: 1 country
• Sites: 1

Brief Summary

What is the best medication for hormonal stimulation in cycles with high intra-uterine insemination: tablets of Clomifen (5 days) followed by tablets of Ethinyl Estradiol (5 days) or daily injections with Human Menopausal Gonadotropin (Menopur)?

Conditions

Subfertility

Outcome Measures

Primary Outcomes (1)

• pregnancy rate

  on average 30 days if not pregnant and 12 weeks if pregnant

Study Arms (2)

Tablets

ACTIVE COMPARATOR

Clomifen (5 days) followed by Ethinyl Estradiol (5 days)

Drug: Clomifen, Ethinyl Estradiol

human menopausal gonadotropins

ACTIVE COMPARATOR

Daily Injections

Drug: Menotropins

Interventions

Clomifen, Ethinyl Estradiol DRUG

starting on day 2 or 3 of the cycle: 1 tablet of Clomifen each day, for 5 days in a row. Dose 50mg or in subsequent cycles, 25 mg or 100 mg or 150 mg. After the 5 days of Clomifen, one tablet of Ethinyl Estradiol 50 mg per day, for 5 days in a row or until beta hCG is injected

Tablets

Menotropins DRUG

Starting on day 2 or 3 of the cycle, a daily subcutaneous injection of 37.5 IU or 75.0 IU

human menopausal gonadotropins

Eligibility Criteria

• Age: 18 Years - 42 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• women younger than 42 years old
• infertility of at least one year
• normal tubal, pelvic and uterine anatomy
• semen with total motility count of at least 5 million (at least one sample)

You may not qualify if:

• premature ovarian failure
• medical history of tubal or ovarian surgery
• tubal or pelvic adhesions

Sponsors & Collaborators

• University Hospital, Gasthuisberg: lead

Study Sites (1)

Leuven University Fertility Center

Leuven, Vlaams Brabant, 3000, Belgium

Location

Related Publications (1)

• Peeraer K, Debrock S, De Loecker P, Tomassetti C, Laenen A, Welkenhuysen M, Meeuwis L, Pelckmans S, Mol BW, Spiessens C, De Neubourg D, D'Hooghe TM. Low-dose human menopausal gonadotrophin versus clomiphene citrate in subfertile couples treated with intrauterine insemination: a randomized controlled trial. Hum Reprod. 2015 May;30(5):1079-88. doi: 10.1093/humrep/dev062. Epub 2015 Mar 18.

  PMID: 25788569 DERIVED

MeSH Terms

Conditions

Infertility

Interventions

Clomiphene; Ethinyl Estradiol; Menotropins

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Stilbenes; Benzylidene Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Norpregnatrienes; Norpregnanes; Norsteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Estrogenic Steroids, Alkylated; Estradiol Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Gonadotropins, Pituitary; Gonadotropins; Peptide Hormones; Pituitary Hormones, Anterior; Pituitary Hormones; Peptides; Amino Acids, Peptides, and Proteins; Biological Products; Complex Mixtures

Study Officials

• Thomas D'Hooghe, MD PhD

  University Hospital, Gasthuisberg

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Profsessor Medical Doctor

Study Record Dates

• First Submitted: March 28, 2012
• First Posted: April 3, 2012
• Study Start: September 1, 2004
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2011
• Last Updated: September 10, 2014

Record last verified: 2014-09

Locations

BE (1)