- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01100346
Predictive Factors of Ovarian Response in Ovulation Induction With Intrauterine Insemination of a Gonal-f Low-dose Regimen
A Prospective, Single Center, Observational Study on the Predictive Factors of Ovarian Response in Ovulation Induction (OI) With Intrauterine Insemination (IUI) of a Gonal-f Low-dose Step-up Regimen
Study Overview
Detailed Description
Ovarian stimulation improves the cycle fecundity rate in part by increasing the number of follicles available for fertilisation and correcting subtle, unpredictable ovulatory dysfunction. Intrauterine insemination is an established treatment for subfertility due to cervical factors, male factors, or unexplained etiology. Ovulation induction aims at the selection of a single follicle that would be able to reach the pre-ovulatory size and rupture. The ovarian sensitivity to FSH (FSH threshold) has to be identified to avoid multiple follicular development and hence, the lowest effective dose of FSH should be used in treating infertility.
Treatment in subjects is individualised and is monitored by serum estradiol (E2) measurements and ultrasound scans of the ovaries to assess the endometrial thickness. It has been observed in earlier studies that in OI for unexplained non-conception, induction of more than one follicle did not improve the ongoing pregnancy rate but increased the risk of multiple pregnancies. Therefore, to reduce the number of multiple pregnancies, in all IUI cycles for unexplained non-conception, monofollicular growth was suggested.
The 'low-dose step-up' protocol is the most suitable method to establish an appropriate FSH threshold, which involves a starting FSH dose of 75 IU/day given for 7 to 14 days. Subsequent dose increments of 37.5 IU/day at weekly intervals is determined based on the ovarian response, usually when a follicle of diameter ≥10 mm is not seen in the ovaries. Human chorionic gonadotrophin (hCG) is then injected when the leading follicle is ≥18 mm in diameter.
OBJECTIVES
Primary objective:
- To describe the outcome of treatment in a cohort of subjects undergoing OI/IUI therapy using Gonal-f
Secondary objective:
- To explore the predictive factors of ovarian response in OI/IUI therapy using a low-dose step-up regimen
This study is planned to enrol 30 female subjects from 1 centre in Taiwan. Each subject can receive up to 3 treatment cycles. Before undergoing a controlled ovarian stimulation with Gonal-f, a thorough gynaecologic and endocrinologic evaluation of the subject will be performed and the subjects will be given the first administration of Gonal-f low dose step up regimen for the controlled ovarian stimulation at the baseline visit. The objective of the Gonal-f therapy is to develop a single mature graafian follicle from which the ovum will be liberated after the administration of hCG. If a subject fails to respond adequately after 4 weeks of treatment, the cycle will be abandoned and the subject would recommence the treatment at a higher starting dose than in the abandoned cycle. If an excessive response is obtained, treatment would be stopped and hCG administration will be withheld and in the next cycle the treatment would start at a dosage lower than that of the previous cycle. Each enrolled subject will be followed up until the confirmation of her pregnancy status.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Taipei, Taiwan
- Far Eastern Memorial Hospital, No.21 Nan-Ya S. Rd., Sec.2 Pan-Chiao
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of follicles 11-15 mm and ≥ 16 mm in diameter, estradiol (E2) levels and endometrial thickness
Time Frame: On the day of hCG administration (during 24-48 hrs after the last Gonal-f injection)
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On the day of hCG administration (during 24-48 hrs after the last Gonal-f injection)
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Total dose of Gonal-f used during stimulation, threshold of Gonal-f dose (daily dose of Gonal-f when follicular growth is > 11 mm in diameter)and duration of Gonal-f treatment
Time Frame: During the period of ovarian stimulation
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During the period of ovarian stimulation
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Outcomes of the treatment (Pregnancy status)
Time Frame: Stimulation start to pregnancy assessment
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Clinical pregnancy, multiple pregnancy, miscarriage, cycle cancellation, Ovarian hyperstimulation syndrome (OHSS) and severity.
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Stimulation start to pregnancy assessment
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Proportion of subjects with monofollicular development
Time Frame: On the day of hCG administration (during 24-48 hrs after the last Gonal-f injection)
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On the day of hCG administration (during 24-48 hrs after the last Gonal-f injection)
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Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- EMR 700623-509
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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