Status:
COMPLETED
To Investigate Efficacy and Safety of a Single Injection of Org 36286 for Ovarian Stimulation Using Daily Recombinant FSH as Reference (Ensure)(P05690/MK-8962-001)
Lead Sponsor:
Organon and Co
Conditions:
Infertility
Eligibility:
FEMALE
18-36 years
Phase:
PHASE3
Brief Summary
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 ovar...
Detailed Description
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...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- History of/or any current (treated) endocrine abnormality;
- History of ovarian hyper-response or ovarian hyperstimulation syndrome
- (OHSS);
- 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.
Key Trial Info
Start Date :
December 28 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 15 2007
Estimated Enrollment :
397 Patients enrolled
Trial Details
Trial ID
NCT00702845
Start Date
December 28 2006
End Date
November 15 2007
Last Update
June 18 2024
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