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Predictive Factors of Ovarian Response in Ovulation Induction With Intrauterine Insemination of a Gonal-f Low-dose Regimen

NCT01100346 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 30

Last updated 2014-03-18

No results posted yet for this study

Summary

This is a single center, prospective, observational study on the use of Gonal-f in controlled ovarian hyperstimulation (COH) in subjects undergoing ovulation induction/ intrauterine insemination (OI/IUI) therapy across Taiwan. It has been observed in the previous studies that COH with follicle stimulating hormone (FSH) is considered as one of the positive predictors of an ongoing pregnancy. Many studies in the past have tried to predict the FSH threshold, defined as the FSH dose on the day when a follicle is \>10 mm in diameter, but no studies have been conducted to date to determine the predictive factors for a monofollicular development after COH in IUI cycles. Monofollicular growth contributes significantly to the reduction of multiple pregnancies and thus minimize the risks associated with such pregnancies. This study would provide preliminary data on the factors associated with a monofollicular development in Gonal-f treated cycles using a low dose step-up regimen.

Conditions

Interventions

DRUG

Gonal-f (Follitropin alpha)

A starting dose of 75 IU/day subcutaneously is maintained for a period of 7 to 14 days. The follitropin alpha dose would be subsequently increased by 37.5 IU/day at weekly intervals based on the ovarian response.

Sponsors & Collaborators

  • Merck Ltd., Taiwan

    collaborator INDUSTRY

  • Merck KGaA, Darmstadt, Germany

    lead INDUSTRY

Principal Investigators

  • Medical Responsible · Merck Ltd., Taiwan

Eligibility

Min Age
20 Years
Max Age
35 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-01-31
Primary Completion
2010-09-30
Completion
2010-09-30

Countries

  • Taiwan

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01100346 on ClinicalTrials.gov