corifollitropin alfa in participants undergoing repeated controlled ovarian stimulation (cos) cycles using a multiple dose gonadatropin releasing hormone (gnrh) antagonist protocol (study 38825)(p05714)

Conditions: In Vitro Fertilization

Summary: the objective of the trial is to assess the non-immunogenicity and safety of corifollitropin alfa (also known as org 36286, sch 900962 and mk-8962) in participants undergoing repeated cos cycles using a multiple dose gnrh antagonist protocol.

this trial is designed as an open-label, uncontrolled, repeated cycle trial to assess the non-immunogenicity and safety of corifollitropin alfa in participants undergoing repeated cos cycles for in vitro fertilization (ivf) or intracytoplasmic sperm injection (icsi) using a multiple dose gnrh antagonist protocol. the trial period per participant will cover 1, 2 or 3 cos treatment cycles and no more than three (in-between two stimulation cycles) frozen-thawed embryo transfer (ftet) cycles following either or both of the first two treatment cycles. in each stimulation cycle, participants receive a single injection of corifollitropin alfa and one week later, treatment is continued with a daily dose of any fsh-containing preparation up to the day of (rec)hcg administration for final oocyte maturation. assessment of anti-corifollitropin alfa antibodies and local tolerance after corifollitropin alfa injection are important safety endpoints in this trial.

Eligibility criteria:
inclusion criteria: * females of couples with an indication for cos and ivf or icsi; * \>=18 and \<=39 years of age at the time of signing informed consent; * body weight \> 60 kg and body mass index (bmi) \>=18 and \<=29 kg/m\^2; * normal menstrual cycle length: 24-35 days; * availability of ejaculatory sperm (use of donated and/or cryopreserved sperm is allowed); * willing and able to sign informed consent. exclusion criteria: * history of or any current (treated) endocrine abnormality; * history of ovarian hyper-response or history of ovarian hyperstimulation syndrome (ohss); * history of or current polycystic ovary syndrome (pcos); * more than 20 basal antral follicles (size: \<11 mm, both ovaries combined) as measured on uss in the early follicular phase (menstrual cycle day 2-5); * less than 2 ovaries or any other ovarian abnormality, including endometrioma \>10 mm (visible on uss); * presence of unilateral or bilateral hydrosalpinx (visible on uss); * more than three unsuccessful cos cycles since the last established ongoing pregnancy (if applicable); * history of non- or low ovarian response to fsh/human menopausal gonadotrophin (hmg) treatment; * fsh \> 12 iu/l or luteinizing hormone (lh) \> 12 iu/l as measured by the local laboratory (sample taken during the early follicular phase: menstrual cycle day 2-5); * any clinically relevant abnormal laboratory value based on a sample taken during the screening phase, including abnormal cervical smear (papanicolaou \[pap\]\>=iii, cervical intraepithelial neoplasia \[cin\]\>=1); * contraindications for the use of gonadotropins (e.g. tumors, pregnancy/lactation, undiagnosed vaginal bleeding, hypersensitivity, ovarian cysts) or gnrh antagonists (e.g. hypersensitivity, pregnancy/lactation); * recent history of or current epilepsy, human immunodeficiency virus (hiv) infection, thrombophilia, diabetes or cardiovascular, gastro-intestinal, hepatic, renal, or pulmonary disease; * abnormal karyotyping of the participant or her partner (if karyotyping is performed); * history or presence of alcohol or drug abuse within 12 months prior to signing informed consent; * previous use of corifollitropin alfa; * use of hormonal preparations within 1 month prior to screening; * administration of investigational drugs within three months prior to signing informed consent.

Keywords: infertility pharmacological effects of drugs hormones, hormone substitutes and hormone antagonists pharmacological actions multi-center