临床试验/NCT00702845

NCT00702845已完成3 期

A Phase III, Randomized, Double-blind, Active-controlled, Equivalence Clinical Trial to Investigate the Efficacy and Safety of a Single Injection of 100 µg Org 36286 (Corifollitropin Alfa) to Induce Multifollicular Development for Controlled Ovarian Stimulation (COS) Using Daily Recombinant FSH (recFSH) as a Reference

Organon and Co0 个研究点目标入组 397 人开始时间: 2006年12月28日最近更新: 2024年6月18日

适应症

干预措施

试验速览

阶段: 3 期
状态: 已完成
发起方: Organon and Co
入组人数: 397
主要终点: Number of Cumulus-oocyte-complexes Retrieved, Per Attempt

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者记录与标识符相似试验

研究概览

简要总结

Clinical trial objectives are to investigate the efficacy and safety of a single injection of 100 μg Org 36286 in women weighing 60 kg or less to induce multifollicular development for controlled ovarian stimulation (COS), using daily recFSH as a reference.

详细描述

This is a randomized, double-blind, active-controlled, equivalence clinical trial investigating the efficacy and safety of a new treatment regimen with Org 36286, a recombinant gonadotropin applied to initiate and sustain follicular stimulation in COS for Assisted Reproductive Technology (ART). For this regimen, patients receive a single injection of Org 36286 and one week later, treatment is continued with daily recFSH up to the day of triggering final oocyte maturation. In the reference group patients receive daily injections of recFSH up to the day of triggering final oocyte maturation. Equivalence between the two treatment groups in the number of oocytes retrieved is the primary objective of this trial.

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Parallel
主要目的: Treatment
盲法: Double (Participant, Investigator)

入排标准

年龄范围: 18 Years 至 36 Years（Adult）
性别: Female
接受健康志愿者: 否

入选标准

•Females of couples with an indication for COS and IVF or ICSI;
•>=18 and <= 36 years of age at the time of signing informed consent;
•Body weight <= 60 kg and BMI >= 18 and <= 32 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.

排除标准

•History of/or any current (treated) endocrine abnormality;
•History of ovarian hyper-response or ovarian hyperstimulation syndrome
•History of/or current polycystic ovary syndrome (PCOS);
•More than 20 basal antral follicles <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 hydrosalphinx (visible on USS);
•Presence of any clinically relevant pathology affecting the uterine cavity or fibroids >= 5 cm;
•More than three unsuccessful IVF cycles since the last established ongoing
•pregnancy (if applicable);
•History of non- or low ovarian response to FSH/hMG treatment;
•History of recurrent miscarriage (3 or more, even when unexplained);
•FSH > 12 IU/L or 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;
•Contraindications for the use of gonadotropins (e.g. tumors, pregnancy/lactation, undiagnosed vaginal bleeding, hypersensitivity, ovarian cysts);
•Recent history of/or current epilepsy, HIV infection, diabetes, cardiovascular,
•gastro-intestinal, hepatic, renal or pulmonary disease;
•Abnormal karyotyping of the patient or her partner (if karyotyping is performed);
•Smoking more than 5 cigarettes per day;
•History or presence of alcohol or drug abuse within 12 months prior to signing informed consent;
•Previous use of Org 36286;
•Use of hormonal preparations within 1 month prior to randomization;
•Hypersensitivity to any of the concomitant medication prescribed as part of the treatment regimen in this protocol;
•Administration of investigational drugs within three months prior to signing informed consent.

研究组 & 干预措施

corifollitropin alfa 100 µg

Experimental

Participants received a single subcutaneous (SC) injection of corifollitropin alfa 100 μg (Org 36286) on Day 2 or 3 of the menstrual cycle and daily placebo-recombinant Follicle Stimulating Hormone (recFSH) injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants also received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including Day of Human Chorion Gonadotropin (hCG) administration. Participants also received Gonadotropin Releasing Hormone (GnRH) antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including the Day of hCG (10,000 or 5,000 IU/USP). Participants also received progesterone (at least 600 mg/day vaginally or 50 mg/day by intramuscular [IM] injection), starting on day of oocyte pick-up (OPU) and continuing for at least 6 weeks or up to menses.

干预措施: corifollitropin alfa (Org 36286) (Drug)

corifollitropin alfa 100 µg

Experimental

干预措施: gonadatropin releasing hormone (GnRH) antagonist (ganirelix) (Drug)

corifollitropin alfa 100 µg

Experimental

干预措施: human chorion gonadatropin (hCG) (Drug)

corifollitropin alfa 100 µg

Experimental

干预措施: progesterone (Biological)

corifollitropin alfa 100 µg

Experimental

干预措施: placebo-recFSH (follitropin alfa) (Drug)

corifollitropin alfa 100 µg

Experimental

干预措施: open-label recFSH (Biological)

recFSH 150 IU

Active Comparator

Participants in the reference group received a single SC injection of placebo-corifollitropin alfa administered on Day 2 or 3 of the menstrual cycle and daily SC recFSH 150 IU injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants also received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including the day of hCG (10,000 or 5,000 IU/USP) administration. Participants also received the GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including the Day of hCG. Participants also received progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on the day of OPU and continuing for at least 6 weeks or up to menses.

干预措施: recFSH (follitropin beta) (Drug)

recFSH 150 IU

Active Comparator

干预措施: gonadatropin releasing hormone (GnRH) antagonist (ganirelix) (Drug)

recFSH 150 IU

Active Comparator

干预措施: human chorion gonadatropin (hCG) (Drug)

recFSH 150 IU

Active Comparator

干预措施: progesterone (Biological)

recFSH 150 IU

Active Comparator

干预措施: placebo-corifollitropin alfa (Drug)

recFSH 150 IU

Active Comparator

干预措施: open-label recFSH (Biological)

结局指标

主要结局

Number of Cumulus-oocyte-complexes Retrieved, Per Attempt

时间窗: One COS cycle with cumulus-oocyte-complex retrieval (up to a maximum total duration of 21 days)

The primary efficacy parameter was defined as the number of cumulus-oocyte-complexes retrieved from participants in a controlled ovarian stimulation (COS) cycle for in vitro fertilization (IVF) and/or intracytoplasmic sperm injection (ICSI). For participants who did not have cumulus-oocyte-complex retrieval, the number retrieved was set to zero.

次要结局

Total Dose of recFSH Administered(One COS cycle (up to a maximum total duration of 19 stimulation days))
Total Dose of recFSH Administered From Day 8 Onwards(Stimulation Day 8 of COS cycle up to day of hCG administration (up to a maximum total duration of 19 stimulation days))
Number of Days Treated With recFSH(One COS cycle (up to a maximum total duration of 19 stimulation days))
Total Duration of Stimulation (Days)(One COS cycle (up to a maximum total duration of 19 stimulation days))
Serum Follicle Stimulating Hormone (FSH) Levels (Restricted to Participants With hCG Injection)(Predose up to 2 weeks after ET (up to maximum of 6 weeks))
Serum Lutenizing Hormone (LH) Levels (Restricted to Participants With hCG Injection)(Predose up to 2 weeks after ET (up to maximum of 6 weeks))
Serum Estradiol (E2) Levels (Restricted to Participants With hCG Injection)(Predose up to 2 weeks after ET (up to maximum of 6 weeks))
Serum Progesterone (P) Levels (Restricted to Participants With hCG Injection)(Predose up to 2 weeks after ET (up to maximum of 6 weeks))
Serum Inhibin-B Levels (Restricted to Participants With hCG Injection)(Predose up to 2 weeks after ET (up to maximum of 6 weeks))
Number and Size Distribution of Follicles During Stimulation and on the Day of hCG Administration(Predose up to day of hCG administration (up to a maximum total duration of 19 stimulation days, including day of hCG administration))
Number and Quality of Oocytes Assessed Prior to ICSI (Restricted to Participants With ICSI Only)(Up to 36 hours after administration of hCG)
Fertilization Rate(Up to 10 weeks after ET)
Number and Quality of Embryos Obtained at Day 3 (Restricted to Participants With IVF and/or ICSI)(Post fertilization Day 3 (up to a maximum of 2 days after hCG administration))
Implantation Rate for Participants With ET(Up to 6 weeks after ET within a treatment cycle (up to a maximum 10 weeks))
Number of Participants With Miscarriages(Up to 10 weeks after ET (up to a maximum of 14 weeks))
Number of Participants With Pregnancies(Up to 10 weeks after ET (up to a maximum of 14 weeks))

研究者

发起方

Organon and Co

申办方类型

Industry

责任方

Sponsor

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