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

• Status: Terminated
• Trial end date: 2010-09-01
• Target enrollment: 0
• Participant gender: Female

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.

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Merck KGaA; Merck KGaA, Darmstadt, Germany
• Collaborator: Merck Ltd., Taiwan
• Treatments: Follicle Stimulating Hormone

Criteria

Inclusion Criteria:

• Female subjects aged between 20 and 35 years

• Subjects with regular menstrual cycle of 25 - 35 days

• Subjects with both ovaries

• Subjects with normal uterine cavity as investigated by either ultrasound scan or hysteroscopy and patent fallopian tube

• Subjects with baseline serum FSH level within normal range of the clinic

• Subjects whose male partner's semen is considered adequate for IUI in accordance to the centre's standard practice

Exclusion Criteria:

• Subjects with any contraindication to being pregnant and/or carrying a pregnancy to term

• Subjects with extrauterine pregnancy or abortion in the past 3 months

• Subjects with abnormal gynaecological bleeding of undetermined origin

• Subjects with history of OHSS

• Subjects with known hypersensitivity to recombinant FSH preparations or any of their recipients