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

NCT01100346 | Terminated

• 1 other identifier: EMR 700623-509
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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

Infertility

Keywords

Ovulation induction; Intrauterine insemination; Gonal-f; Controlled ovarian stimulation; Infertility

Outcome Measures

Primary Outcomes (3)

• Number of follicles 11-15 mm and ≥ 16 mm in diameter, estradiol (E2) levels and endometrial thickness

  On the day of hCG administration (during 24-48 hrs after the last Gonal-f injection)

• 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

  During the period of ovarian stimulation

• Outcomes of the treatment (Pregnancy status)

  Clinical pregnancy, multiple pregnancy, miscarriage, cycle cancellation, Ovarian hyperstimulation syndrome (OHSS) and severity.

  Stimulation start to pregnancy assessment

Secondary Outcomes (1)

• Proportion of subjects with monofollicular development

  On the day of hCG administration (during 24-48 hrs after the last Gonal-f injection)

Interventions

Gonal-f (Follitropin alpha) DRUG

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.

Also known as: Gonal-f

Eligibility Criteria

• Age: 20 Years - 35 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Female subjects with regular menstrual cycles aged between 20 and 35 years in Taiwan.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Merck KGaA, Darmstadt, Germany: lead
• Merck Ltd., Taiwan: collaborator

Study Sites (1)

Far Eastern Memorial Hospital, No.21 Nan-Ya S. Rd., Sec.2 Pan-Chiao

Taipei, Taiwan

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum

MeSH Terms

Conditions

Infertility

Interventions

follitropin alfa; Glycoprotein Hormones, alpha Subunit

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Chorionic Gonadotropin; Gonadotropins; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Follicle Stimulating Hormone; Gonadotropins, Pituitary; Luteinizing Hormone; Pituitary Hormones, Anterior; Pituitary Hormones; Thyrotropin; Placental Hormones; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Medical Responsible

  Merck Ltd., Taiwan

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 10, 2010
• First Posted: April 8, 2010
• Study Start: January 1, 2010
• Primary Completion: September 1, 2010
• Study Completion: September 1, 2010
• Last Updated: March 18, 2014

Record last verified: 2012-11

Locations

TW (1)