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

• Status: Completed
• Trial end date: 2008-09-01
• Target enrollment: 0
• Participant gender: Female

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Merck KGaA; Merck KGaA, Darmstadt, Germany
• Treatments: Chorionic Gonadotropin; Follicle Stimulating Hormone; Hormones

Criteria

Inclusion Criteria :

• 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

Exclusion Criteria:

• 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

• Planning to undergo experimental procedures such as blastomere biopsy, or

• Any known autoimmune disease