Pregnancy and Neonatal Follow-up of Ongoing Pregnancies Established in Clinical Trial 38833 (P05783) (Care)

February 1, 2022 updated by: Organon and Co

Pregnancy and Neonatal Follow-up of Ongoing Pregnancies Established After Controlled Ovarian Stimulation in Clinical Trial 38833 for Org 36286 (Corifollitropin Alfa)

The objective of this trial is to evaluate whether corifollitropin alfa (MK-8962, Org 36286) treatment for the induction of multifollicular growth in women undergoing Controlled Ovarian Stimulation (COS) prior to in vitro fertilization (IVF) or Intracytoplasmic Sperm Injection (ICSI) is safe for pregnant participants and their offspring.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is a follow-up protocol to prospectively monitor pregnancy, delivery, and neonatal outcomes of all women who were treated with corifollitropin alfa and became pregnant during the base Trial 38833. For this follow-up trial (38834), no investigational products will be administered and no study specific assessments are required, but information will be obtained as per standard clinical practice.

Study Type

Observational

Enrollment (Actual)

15

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 39 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Women with an ongoing pregnancy at least 10 weeks after embryo transfer in Trial 38833 were enrolled in this trial.

Description

Inclusion Criteria:

  • Participants who received one dose of corifollitropin alfa in Trial 38833;
  • Ongoing pregnancy confirmed by ultrasound at least 10 weeks after embryo transfer in Trial 38833;
  • Able and willing to give written informed consent.

Exclusion Criteria:

  • None

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Corifollitropin alpha 100 ug
In the base study (P05788, 38833, NCT00702351), participants were pre-treated with daily subcutaneous (SC) injections of 0.1 mg triptorelin started between Day 21 and 24 of the menstrual cycle (mid luteal phase). After suppression of endogenous luteinizing hormone (LH) and follicle stimulating hormone (FSH) was confirmed by estradiol (E2) and progesterone (P) measurements, a single dose of corifollitropin alpha 100 μg was administered in participants weighing <= 60 kg. From stimulation Day 8 onwards, treatment was continued with daily SC of recombinant follicle stimulating hormone (recFSH) injections (maximally 200 IU) up to and including the day of administration of human chorionic gonadotprophin (hCG). No study medications were administered in the present P05783 study (38834, NCT00702520).
Drug: Corifollitropin alpha (MK-8962, Org 36286) 100 ug
Subcutaneous administration of corifollitropin alpha at a dose of 100 ug
Drug: Triptorelin
Daily SC injections of 0.1 mg triptorelin started between Day 21 and 24 of the menstrual cycle (mid luteal phase).
Biological: Recombinant follicle stimulating hormone (recFSH)
From stimulation Day 8 onwards, treatment was continued with daily SC of recFSH injections (maximally 200 IU) up to and including the day of administration of hCG.
Biological: Human chorionic gonadotprophin (hCG).
HCG was administered as a single subcutaneous injection of 5,000 to 10,000 international units.
Corifollitropin alpha 150 ug
In the base study (P05788, 38833, NCT00702351), participants were pre-treated with daily SC injections of 0.1 mg triptorelin started between Day 21 and 24 of the menstrual cycle (mid luteal phase). After suppression of endogenous LH and FSH was confirmed by E2 and P measurements, a single dose of corifollitropin alpha 150 μg was administered in participants weighing >= 50 kg. From stimulation Day 8 onwards, treatment was continued with daily SC of recFSH injections (maximally 200 IU) up to and including the day of administration of hCG. No study medications were administered in the present P05783 study (38834, NCT00702520).
Drug: Triptorelin
Daily SC injections of 0.1 mg triptorelin started between Day 21 and 24 of the menstrual cycle (mid luteal phase).
Biological: Recombinant follicle stimulating hormone (recFSH)
From stimulation Day 8 onwards, treatment was continued with daily SC of recFSH injections (maximally 200 IU) up to and including the day of administration of hCG.
Biological: Human chorionic gonadotprophin (hCG).
HCG was administered as a single subcutaneous injection of 5,000 to 10,000 international units.
Drug: Corifollitropin alpha (MK-8962, Org 36286) 150 ug
Subcutaneous administration of corifollitropin alpha at a dose of 150 ug

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Expectant Mothers Experiencing Adverse Events (AEs)
Time Frame: Up to 1 Year
An AE is any unfavorable and unintended change in the structure, function or chemistry of the body temporally associated with study drug administration whether or not considered related to the use of the study drug.
Up to 1 Year
Number of Expectant Mothers Experiencing Serious AEs (SAEs)
Time Frame: Up to 1 Year
An AE or suspected adverse reaction is considered "serious" if, in the view of either the investigator or sponsor, it results in any of the following outcomes: death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, or a congenital anomaly/birth defect. Important medical events that may not result in death, be life-threatening, or require hospitalization may be considered serious when, based upon appropriate medical judgment, they may jeopardize the participant and may require medical or surgical intervention to prevent one of the outcomes listed in this definition.
Up to 1 Year
Number of Infants Experiencing AEs
Time Frame: Up to 1 Year
An AE is any unfavorable and unintended change in the structure, function or chemistry of the body temporally associated with study drug administration whether or not considered related to the use of the study drug.
Up to 1 Year
Number of Infants Experiencing SAEs
Time Frame: Up to 1 Year
An AE or suspected adverse reaction is considered "serious" if, in the view of either the investigator or sponsor, it results in any of the following outcomes: death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, or a congenital anomaly/birth defect. Important medical events that may not result in death, be life-threatening, or require hospitalization may be considered serious when, based upon appropriate medical judgment, they may jeopardize the participant and may require medical or surgical intervention to prevent one of the outcomes listed in this definition.
Up to 1 Year
Take-Home Baby Rate
Time Frame: Birth of a one or more live babies (Up to 1 year)
The take-home baby rate was calculated as the number of participants with a least one live born infant in the follow-up study (P05783, 38834, NCT00702520) relative to the number of participants treated with Corifollitropin alpha in the base study (P05788, 38833, NCT00702351).
Birth of a one or more live babies (Up to 1 year)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Organon and Co

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2006

Primary Completion (Actual)

November 7, 2007

Study Completion (Actual)

January 15, 2008

Study Registration Dates

First Submitted

June 18, 2008

First Submitted That Met QC Criteria

June 18, 2008

First Posted (Estimate)

June 20, 2008

Study Record Updates

Last Update Posted (Actual)

February 3, 2022

Last Update Submitted That Met QC Criteria

February 1, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P05783
  • 38834 (Other Identifier: Organon)
  • MK-8962-010 (Other Identifier: Merck)
  • 2005-000062-40 (EudraCT Number)

Plan for Individual participant data (IPD)

Study Data/Documents

  1. CSR Synopsis

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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