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)

NCT ID: NCT00702351

Last Updated: 2022-02-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-12-09
• Study Completion Date: 2007-07-11

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.

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.

Conditions

In Vitro Fertilization

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Arm 1

150 µg Org 36286 (corifollitropin alfa)

Group Type: EXPERIMENTAL

Org 36286 (corifollitropin alfa)

Intervention Type: 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).

Arm 2

100 µg Org 36286 (corifollitropin alfa)

Group Type: EXPERIMENTAL

Org 36286 (corifollitropin alfa)

Intervention Type: 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).

Interventions

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).

Intervention Type: DRUG

Other Intervention Names

corifollitropin alfa

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 39 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Organon and Co

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

References

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.

Reference Type: RESULT

PMID: 20149360 (View on PubMed)

Other Identifiers

EudraCT #: 2004-004968-68;

Identifier Type: -

Identifier Source: secondary_id

38833

Identifier Type: -

Identifier Source: secondary_id

P05788

Identifier Type: -

Identifier Source: org_study_id