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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

682 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-09-26

Study Completion Date

2009-05-15

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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In Vitro Fertilization

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Corifollitropin alfa 150 µg

Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of recombinant Human Chorion Gonadotropin (\[rec\]hCG) (5,000-10,000 IU/250 µg). Administration of (rec)hCG occurred when 3 follicles ≥17 mm were observed on ultrasound scan (USS). Daily dosing with Follicle Stimulating Hormone (FSH) (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone for luteal phase support was administered starting on the day of oocyte pick-up (34-36 hours after \[rec\]hCG) and continued for approximately 6 weeks. After COS cycles 1 and 2, Frozen-Thawed Embryo Transfer cycles (up to 3 after each COS cycle) could occur.

Group Type EXPERIMENTAL

Corifollitropin alfa

Intervention Type DRUG

Corifollitropin alfa 150 µg administered as a single subcutaneous dose.

FSH

Intervention Type BIOLOGICAL

FSH administerd subcutaneously at a dose not to exceed 225 IU/day.

GnRH antagonist

Intervention Type BIOLOGICAL

GnRH antagonist administered subcutaneously at a dose of 0.25 mg/day.

(rec)hCG

Intervention Type BIOLOGICAL

(rec)hCG administered subcutaneously at a dose of 5,000-10,000 IU/250 µg.

Progesterone

Intervention Type DRUG

Progesterone administered vaginally at a dose of at least 600 mg/day.

Interventions

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Corifollitropin alfa

Corifollitropin alfa 150 µg administered as a single subcutaneous dose.

Intervention Type DRUG

FSH

FSH administerd subcutaneously at a dose not to exceed 225 IU/day.

Intervention Type BIOLOGICAL

GnRH antagonist

GnRH antagonist administered subcutaneously at a dose of 0.25 mg/day.

Intervention Type BIOLOGICAL

(rec)hCG

(rec)hCG administered subcutaneously at a dose of 5,000-10,000 IU/250 µg.

Intervention Type BIOLOGICAL

Progesterone

Progesterone administered vaginally at a dose of at least 600 mg/day.

Intervention Type DRUG

Other Intervention Names

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Org 36286 SCH 900962 MK-8962

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

39 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No