Investigation of a Long-Acting Follicle Stimulating Hormone in Infertile Women Undergoing Assisted Reproductive Technology (ART)

Completed · Phase 2

Conditions studied: Infertility

In brief

This is a Phase 2, interventional, prospective, multi-center, randomized, assessor-blind, active-comparator, dose-finding study to evaluate a new investigational long-acting follicle stimulating hormone (FSH) in infertile women who are undergoing an assisted reproductive technology (ART) procedure (In vitro fertilization/Intra cytoplasmic sperm injection \[IVF/ICSI\]). This study will compare 3 doses of the investigational drug versus a currently marketed drug follitropin alfa (Gonal-f® revised formulation female \[RFF\] Pen) in regards to the number of fertilized oocytes.

Key facts

Study ID

NCT00505752

Run by

Merck KGaA, Darmstadt, Germany

People needed

520

Starts

2007-01-01

Expected to finish

2008-09-01

Last updated by the study team

2014-02-13

Who can join

Age: 18 and older, up to 36. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Infertility and desire to conceive, justifying ART treatment
• Age between 18 and 36 years, inclusive, at time of informed consent
• Body mass index (BMI) 18 to 30 kilogram per square meter (kg/m\^2), inclusive
• Regular spontaneous menstrual cycles of 21 to 35 days
• Presence of both ovaries
• Transvaginal ultrasound within 6 weeks and hysterosalpingogram, hysterosonogram or hysteroscopy within 2 years prior to beginning OCP treatment, showing no clinically significant uterine abnormality, which, in the Investigator's opinion, could impair embryo implantation or pregnancy continuation
• Normal early follicular phase (Day 2-4) serum FSH level, according to the local laboratory
• Normal serum thyroid stimulating hormone (TSH) level, according to the local laboratory
• Papanicolaou (PAP) smear test without clinically significant abnormalities within the last 6 months prior to beginning oral contraceptive therapy,
• Negative pregnancy test prior to beginning GnRH-agonist therapy
• Male partner with semen analysis which is at least adequate for ICSI within last 6 months prior to beginning GnRH agonist therapy, according to local laboratory
• Willing and able to comply with the protocol
• Voluntary provision of written informed consent, prior to any study-related procedure that was not part of normal medical care, with the understanding that the subject could withdraw consent at any time without prejudice to her future medical care, and
• Willingness to provide follow-up information on babies born as part of this study
• For subjects recruited at PK sub-study centers, voluntary provision of written informed consent to participate in the PK sub-study

You may not qualify if…

• Subject who require a starting dose of FSH greater than (>) 150 international unit per day (IU/day), in the opinion of the Investigator
• Screening ultrasound demonstrating more than 12 follicles less than (<) 11 mm mean diameter in either ovary
• Two or more previous ART cycles (consecutive or not) with poor response to gonadotrophin, defined as less than or equal to (=<)3 oocytes retrieved
• Three or more previous consecutive ART cycles without a biochemical or clinical pregnancy
• Previous failure of fertilization with ICSI
• A previous ART attempt in which there were no adequate or motile sperm before or after the processing of ejaculated sperm
• Previous severe OHSS
• History or presence of tumors of the hypothalamus or pituitary gland
• History or presence of ovarian, uterine or mammary cancer
• History or presence of ovarian enlargement or cyst of unknown etiology, or presence of ovarian cyst >25 mm on the day of randomization
• Presence of endometriosis Grade III - IV
• Presence of uni- or bilateral hydrosalpinx
• Abnormal gynecological bleeding of undetermined origin
• Contraindication to being pregnant and/or carrying a pregnancy to term
• History of >= 3 clinical or preclinical (absence of gestational sac) miscarriages due to any cause
• Extra-uterine pregnancy within the 3 months prior to randomization
• Clinically significant concurrent disease that would have compromised subject safety or interfered with the study assessments
• Known infection with human immunodeficiency virus (HIV), hepatitis B or C virus in the female or male partner
• Known allergy or hypersensitivity to human gonadotrophin preparations or to compounds that are structurally similar to any of the other medications administered during the study
• Any medical condition, which in the judgment of the Investigator may have interfere with the absorption, distribution, metabolism or excretion of r-hFSH
• Any active substance abuse or history of drug, medication or alcohol abuse within 5 years before screening
• ART cycle and/or ovarian stimulation within 30 days prior to informed consent
• Entered previously into this study or simultaneous participation in another clinical trial
• Subject is a smoker consuming more than 5 cigarettes per day
• In the opinion of the Investigator, either assisted hatching or pre-implantation genetic diagnosis is indicated for the subject

Where it is running

• Local US Medical Information Office — Rockland, Massachusetts, United States

Full record on ClinicalTrials.gov

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