Corifollitropin Alfa in Participants Undergoing Repeated Controlled Ovarian Stimulation (COS) Cycles Using a Multiple Dose Gonadatropin Releasing Hormone (GnRH) Antagonist Protocol (Study 38825)(P05714)

• Status: Completed
• Trial end date: 2009-05-15
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Merck Sharp & Dohme Corp.
• Treatments: Hormones; Progesterone

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.