NCT00702351

Brief Summary

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Dec 2005

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 9, 2005

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 26, 2007

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 11, 2007

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

June 18, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 20, 2008

Completed
Last Updated

February 2, 2022

Status Verified

February 1, 2022

Enrollment Period

1.3 years

First QC Date

June 18, 2008

Last Update Submit

February 1, 2022

Conditions

In Vitro Fertilization

Keywords

InfertilityPharmacological effects of drugsDrug therapyHormonesGnRH agonistRecFSHCorifollitropin alfaOpen-label

Outcome Measures

Primary Outcomes (1)

  • serum inhibin-B levels; follicle number and follicle size distribution

    One cycle

Secondary Outcomes (2)

  • 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

    One cycle

  • Number of fertilized oocytes; Fertilization rate; Number and quality of embryos; Implantation rate; Miscarriage rate; Clinical outcome

    One cycle

Study Arms (2)

Arm 1

EXPERIMENTAL

150 µg Org 36286 (corifollitropin alfa)

Drug: Org 36286 (corifollitropin alfa)

Arm 2

EXPERIMENTAL

100 µg Org 36286 (corifollitropin alfa)

Drug: Org 36286 (corifollitropin alfa)

Interventions

Org 36286 (corifollitropin alfa)DRUG

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).

Also known as: corifollitropin alfa
Arm 1Arm 2

Eligibility Criteria

Age18 Years - 39 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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;
  • +5 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Fatemi HM, Oberye J, Popovic-Todorovic B, Witjes H, Mannaerts B, Devroey P. Corifollitropin alfa in a long GnRH agonist protocol: proof of concept trial. Fertil Steril. 2010 Oct;94(5):1922-4. doi: 10.1016/j.fertnstert.2009.12.070. Epub 2010 Feb 10.

    PMID: 20149360RESULT

MeSH Terms

Conditions

Infertility

Interventions

follicle stimulating hormone, human, with HCG C-terminal peptide

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 18, 2008

First Posted

June 20, 2008

Study Start

December 9, 2005

Primary Completion

March 26, 2007

Study Completion

July 11, 2007

Last Updated

February 2, 2022

Record last verified: 2022-02