Low-dose Gonal-f® in Ovulation Induction (NCT01871532) | Clinical Trial Compass
TerminatedPhase 4
Low-dose Gonal-f® in Ovulation Induction
Stopped: Study was terminated because of delays in sourcing replacement Investigational Medicinal Product for the study due to manufacturing delays.
Ireland, United Kingdom24 participantsStarted 2013-07
Plain-language summary
This is a prospective, multicenter, open-label, comparative and parallel-group study of ovulation induction evaluating tailoring of Recombinant follicle stimulating hormone (FSH) treatment using the Gonal-f® prefilled pen in World Health Organization (WHO) Type 2 anovulatory subjects who have previously failed to conceive with clomifene treatment.
Who can participate
Age range18 Years – 37 Years
SexFEMALE
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Inclusion Criteria:
* Subjects eligible for ovulation induction treatment, where monofollicular development is the desired treatment outcome and the dose schedule outlined in the protocol is deemed appropriate
* Premenopausal female subjects, aged between 18 and 37 years inclusive
* Subjects desirous of pregnancy/willing to conceive
* Subjects who are infertile due to chronic anovulation demonstrated by cycle duration of greater than 35 days.
* Subjects who have been treated with clomifene citrate therapy, according to standard site practice, and have failed to ovulate and/or conceive
* Subjects with follicle stimulating hormone (FSH) and prolactin (PRL) serum values within the normal range in the early follicular phase
* Subjects with an overall total antral follicle count greater than 10 (of follicle size greater than or equal to 2 millimeter \[mm\] and less than 11 mm) (that is, total between both ovaries)
* Subjects with at least one patent tube, as documented by recent (within 2 years before treatment assignment) hysterosalpingography (HSG) or hysterosalpingo contrast sonography (HyCoSy)
* Subjects with normal uterine cavity, as documented by recent (within 2 years before treatment assignment) hysteroscopy, HSG or ultrasound scan
* Subjects with body mass index (BMI) greater than 20 and less than or equal to 32 kilogram per square meter (kg/m\^2) (BMI is equal to body weight \[kilogram {kg}\] divided by Height \* Height \[square meter {m\^2}\])
* Subjects with negative …
What they're measuring
1
Percentage of Cycles With Monofollicular Development