A Trial of Single Dose Corifollitropin Alfa's Ability to Induce Multiple Follicular Growth During the First Week of Controlled Ovarian Stimulation for IVF or ICSI (38833)(P05788) (Realize)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00702351
First received: June 18, 2008
Last updated: May 21, 2014
Last verified: May 2014
  Purpose

To evaluate the induction of multiple follicular growth after single dose administration of 100 μg or 150 μg Org 36286 in a long protocol of GnRH agonist.


Condition Intervention Phase
In Vitro Fertilization
Drug: Org 36286 (corifollitropin alfa)
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II, Uncontrolled Pilot Trial to Evaluate That a Single Dose of 100 μg or 150 μg Org 36286 (Corifollitropin Alfa) is Able to Induce Multiple Follicular Growth During the First Week of Controlled Ovarian Stimulation for IVF or ICSI Using a Long Protocol of GnRH Agonist (Study 38833)

Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • serum inhibin-B levels; follicle number and follicle size distribution [ Time Frame: One cycle ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Amount of recFSH needed from Stimulation Day 8 onwards to the Day of hCG; Endocrinological parameters (FSH, LH, E2, P); Number and quality of oocytes retrieved [ Time Frame: One cycle ] [ Designated as safety issue: No ]
  • Number of fertilized oocytes; Fertilization rate; Number and quality of embryos; Implantation rate; Miscarriage rate; Clinical outcome [ Time Frame: One cycle ] [ Designated as safety issue: No ]

Enrollment: 50
Study Start Date: December 2005
Study Completion Date: July 2007
Primary Completion Date: July 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1
150 µg Org 36286 (corifollitropin alfa)
Drug: Org 36286 (corifollitropin alfa)
A single dose of Org 36286 will be administered after down-regulation has been confirmed (E2 below 50 ng/L and P below 1.48 μg/L). The first group comprising subjects weighing >= 50 kg will receive a dose of 150 μg Org 36286 (150 μg dose group). The second group comprising subjects weighing <= 60 kg will receive a dose of 100 μg Org 36286 (100 μg dose group).
Other Name: corifollitropin alfa
Experimental: Arm 2
100 µg Org 36286 (corifollitropin alfa)
Drug: Org 36286 (corifollitropin alfa)
A single dose of Org 36286 will be administered after down-regulation has been confirmed (E2 below 50 ng/L and P below 1.48 μg/L). The first group comprising subjects weighing >= 50 kg will receive a dose of 150 μg Org 36286 (150 μg dose group). The second group comprising subjects weighing <= 60 kg will receive a dose of 100 μg Org 36286 (100 μg dose group).
Other Name: corifollitropin alfa

Detailed Description:

In this trial, all subjects were (pre)treated daily with subcutaneous triptorelin, a GnRH agonist which is known to provide profound suppression of endogenous LH and FSH. It was evaluated whether these down-regulated subjects show an appropriate ovarian response to 100 μg or 150 μg Org 36286 during the first week of stimulation. To evaluate this, follicular growth was measured by USS, and serum inhibin-B and E2 levels were assessed.

  Eligibility

Ages Eligible for Study:   18 Years to 39 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Females of couples with an indication for controlled ovarian stimulation (COS) and IVF or ICSI that have had at least one previous COS cycle with proven normal ovarian response;
  • >=18 and <= 39 years of age at the time of signing informed consent;
  • a. First group: Body weight >= 50 kg and BMI >= 18 and <= 29 kg/m^2; b. Second group: Body weight <= 60 kg and BMI <= 29 kg/m^2;
  • Normal menstrual cycle length: 24-35 days;
  • Ejaculatory sperm (use of donated and/or cryopreserved sperm is allowed);
  • Normal routine diagnostic hysteroscopy and endometrial biopsy;
  • Willing and able to sign informed consent.

Exclusion Criteria:

  • History of or any current (treated) endocrine abnormality;
  • History of ovarian hyper-response1 or history of ovarian hyperstimulation

syndrome (OHSS);

  • History of or current polycystic ovary syndrome (PCOS);
  • A basal antral follicle count > 20 (size < 11 mm, both ovaries combined) on USS during the early follicular phase (menstrual cycle day 2-5);
  • Less than 2 ovaries or any other ovarian abnormality;
  • Presence of unilateral or bilateral hydrosalpinx (visible on USS);
  • Presence of unilateral or bilateral endometriomas (>10 mm; 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/hMG treatment;
  • FSH 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) or GnRH analogues (e.g. hypersensitivity, pregnancy/lactation);
  • Recent history of or current epilepsy, diabetes or cardiovascular, gastro-intestinal, hepatic, renal or pulmonary disease;
  • 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 screening;
  • Administration of investigational drugs within three months prior to signing

informed consent.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

Publications:
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00702351     History of Changes
Other Study ID Numbers: P05788, EudraCT #: 2004-004968-68;, 38833
Study First Received: June 18, 2008
Last Updated: May 21, 2014
Health Authority: Belgium: Federal Agency for Medicinal Products and Health Products

Keywords provided by Merck Sharp & Dohme Corp.:
Infertility
Pharmacological effects of drugs
Drug therapy
Hormones
GnRH agonist
RecFSH
Corifollitropin alfa
Open-label

ClinicalTrials.gov processed this record on August 28, 2014