Pregnancy and Neonatal Follow-up of Ongoing Pregnancies Established in Clinical Trial P05714 (Care Program)(P05715) (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 38825 for Org 36286 (Corifollitropin Alfa)

The objective of this trial is to evaluate whether corifollitropin alfa (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. In addition, a primary efficacy variable, live birth rate, was evaluated.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is a follow-up protocol to prospectively monitor pregnancy, delivery, and neonatal outcomes of women who were treated with corifollitropin alfa and became pregnant after fresh embryo transfer during the base study P05714 (NCT00696878). For this trial, no study specific assessments are required, but information as obtained in standard practice will be used.

Study Type

Observational

Enrollment (Actual)

268

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 fresh embryo transfer in base study P05714 (NCT00696878) were enrolled in this trial.

Description

Inclusion Criteria:

  • Participants who participated in base study P05714 (NCT00696878) and received at least one dose of corifollitropin alfa in base study P05714;
  • Ongoing pregnancy confirmed by ultrasound at least 10 weeks after a fresh embryo transfer in base study P05714;
  • 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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Women/Expectant Mothers - Corifollitropin Alfa 150 µg
In base study P05714 (NCT00696878), up to 3 COS cycles were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of Gonadotropin Releasing Hormone (GnRH) antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of recombinant Human Chorion Gonadotropin ([rec]hCG) (5,000-10,000 IU/250 µg). Daily dosing with Follicle Stimulating Hormone (FSH) (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, Frozen-Thawed Embryo Transfer cycles (up to 3 after each COS cycle) could occur. Participants with confirmed pregnancy at least 10 weeks after fresh embryo transfer in the base study were eligible for this follow-up study. In this follow-up study P05715, no study drugs were administered.
Biological: Corifollitropin alfa
Subcutaneous (SC) administration of corifollitropin alfa at a dose of 150 μg in base study P05714 (NCT00696878). In this follow-up study P05715, no study medications were administered.
Other Names:
  • Org 36286
  • SCH 900962
  • MK-8962
Biological: GnRH antagonist
SC administration of a GnRH antagonist at a dose of 0.25 mg/day in base study P05714 (NCT00696878). In this follow-up study P05715, no study medications were administered.
Biological: (rec)hCG
SC administration of (rec)hCG at a dose of 5,000-10,000 IU/250 µg in base study P05714 (NCT00696878). In this follow-up study P05715, no study medications were administered.
Biological: FSH
SC administration of FSH at a dose not to exceed 225 IU/day in base study P05714 (NCT00696878). In this follow-up study P05715, no study medications were administered.
Drug: Progesterone
Vaginal administration of progesterone at a dose of at least 600 mg/day in base study P05714 (NCT00696878). In this follow-up study P05715, no study medications were administered.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Women With Ongoing Pregnancy After a Corifollitropin Alfa COS Cycle in Base Study and ≥1 Live Born Infant During Follow-up (Live Birth Rate)
Time Frame: Up to approximately 32 months after first dose of corifollitropin alfa in base study P05714 (NCT00696878)
The live birth rate was defined as the number of participants who had an ongoing pregnancy after a corifollitropin alfa COS cycle in base study P05714 (NCT00696878) and who had at least one live born infant during follow-up, divided by the number of participants treated in the base study. For this analysis, it was assumed that any participants with ongoing pregnancy after a COS cycle in base study who did not enroll in follow-up study P05715 had no live born infants.
Up to approximately 32 months after first dose of corifollitropin alfa in base study P05714 (NCT00696878)
Number of Expectant Mothers Experiencing Adverse Events (AEs)
Time Frame: From approximately 10 weeks after fresh ET in base study P05714 up to birth of infant (up to approximately 6 months)
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
From approximately 10 weeks after fresh ET in base study P05714 up to birth of infant (up to approximately 6 months)
Number of Expectant Mothers Experiencing Serious AEs (SAEs)
Time Frame: From approximately 10 weeks after fresh ET in base study P05714 up to birth of infant (up to approximately 6 months)
An SAE was defined as any untoward medical occurrence that at any dose resulted in death, was life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, or was a congenital anomaly/birth defect.
From approximately 10 weeks after fresh ET in base study P05714 up to birth of infant (up to approximately 6 months)
Number of Live Born Infants Experiencing AEs
Time Frame: Up to 12 weeks after birth
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
Up to 12 weeks after birth
Number of Live Born Infants Experiencing SAEs
Time Frame: Up to 12 weeks after birth
An SAE was defined as any untoward medical occurrence that at any dose resulted in death, was life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, or was a congenital anomaly/birth defect.
Up to 12 weeks after birth

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)

February 15, 2007

Primary Completion (ACTUAL)

October 22, 2009

Study Completion (ACTUAL)

January 15, 2010

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

  • P05715
  • 2004-004967-30 (EUDRACT_NUMBER)
  • 38829 (OTHER: Organon)
  • MK-8962-008 (OTHER: Merck)

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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