Pregnancy and Neonatal Follow-up of Ongoing Pregnancies Established in Clinical Trial P05690 (Care Program) (P05710) (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 107012 for the Development of Org 36286 (Corifollitropin Alfa)

The objective of this follow-up study 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is a follow-up protocol to prospectively monitor pregnancy, delivery, and neonatal outcome of women who were treated with corifollitropin alfa or recFSH and became pregnant during the base study P05690 (NCT00702845). For this trial no study specific assessments are required, but information as obtained in standard practice will be used.

Study Type

Observational

Enrollment (Actual)

113

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 36 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 base study P05690 (NCT00702845) were enrolled in this trial.

Description

Inclusion Criteria:

  • Participants who participated in base study P05690 (NCT00702845) and received at least one dose of either corifollitropin alfa (Org 36286) or recFSH in base study P05690;
  • Ongoing pregnancy confirmed by ultrasound at least 10 weeks after embryo transfer in base study P05690;
  • 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
Corifollitropin alfa 100 μg
In follow-up study, no medication or investigational product was administered. In base study P05690 (NCT00702845), participants received single subcutaneous (SC) injection of corifollitropin alfa 100 μg (Org 36286) on Day 2 or 3 of menstrual cycle and daily placebo-recombinant Follicle Stimulating Hormone (recFSH) injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants in base study P05690 also received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including Day of Human Chorion Gonadotropin (hCG) administration. Participants also received Gonadotropin Releasing Hormone (GnRH) antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including Day of hCG (10,000 or 5,000 IU/USP). Participants also received progesterone (at least 600 mg/day vaginally or 50 mg/day by intramuscular [IM] injection), starting on day of oocyte pick-up (OPU) and continuing for at least 6 weeks or up to menses.
Drug: gonadatropin releasing hormone (GnRH) antagonist ganirelix
GnRH antagonist ganirelix administered SC at a dose of 0.25 mg/day under protocol P05690
Biological: progesterone
Under protocol P05690, progesterone was started on the day of oocyte pick-up (OPU) and continued for at least 6 weeks or up to menses. Participants received at least 600 mg/day vaginally or 50 mg/day IM.
Drug: Corifollitropin alfa
Single injection of 100 μg corifollitropin alfa administered under protocol P05690
Other Names:
  • SCH 900962
  • MK-8962
Biological: human chorion gonadotropin (hCG)
hCG 5,000 IU/USP or 10,000 IU/USP administered under protocol P05690
Drug: placebo-recFSH (follitropin beta)
Placebo-recFSH at the equivalent volume of 150 IU/day administered under protocol P05690
Biological: open-label recFSH (follitropin beta)
Open-label recFSH up to a maximum dose of 200 IU/day, administered under protocol P05690
recFSH 150 IU
In follow-up study, no medication or investigational product was administered. In base study P05690 (NCT00702845), participants in the reference group received a single SC injection of placebo-corifollitropin alfa administered on Day 2 or 3 of the menstrual cycle and daily SC recFSH 150 IU injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants also received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including Day of hCG (10,000 or 5,000 IU/USP) administration. Participants also received the GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including the Day of hCG. Participants also received progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on the day of OPU and continuing for at least 6 weeks or up to menses.
Drug: gonadatropin releasing hormone (GnRH) antagonist ganirelix
GnRH antagonist ganirelix administered SC at a dose of 0.25 mg/day under protocol P05690
Biological: progesterone
Under protocol P05690, progesterone was started on the day of oocyte pick-up (OPU) and continued for at least 6 weeks or up to menses. Participants received at least 600 mg/day vaginally or 50 mg/day IM.
Drug: placebo-corifollitropin alfa
Single SC injection of placebo-corifollitropin alfa on Day 2 or 3 of the menstrual cycle, administered under protocol P05690
Biological: human chorion gonadotropin (hCG)
hCG 5,000 IU/USP or 10,000 IU/USP administered under protocol P05690
Biological: open-label recFSH (follitropin beta)
Open-label recFSH up to a maximum dose of 200 IU/day, administered under protocol P05690
Biological: recFSH (follitropin beta)
Daily recFSH administered under protocol P05690
Other Names:
  • Follistim®
  • Puregon®
  • follitropin beta

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Women With ≥1 Live Born Infant During Follow-up (Take-Home Baby Rate)
Time Frame: From approximately 10 weeks after ET in base study P05690 up to birth of infant (up to approximately 6 months)
The Take-Home Baby Rate was defined as the number of participants with an ongoing pregnancy in base study P05690 with at least one live born infant during follow up relative to the number of participants treated in base study.
From approximately 10 weeks after ET in base study P05690 up to birth of infant (up to approximately 6 months)
Number of Expectant Mothers Experiencing Adverse Events (AEs)
Time Frame: From approximately 10 weeks after ET in base study P05690 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 ET in base study P05690 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 ET in base study P05690 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 ET in base study P05690 up to birth of infant (up to approximately 6 months)
Number of 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 can 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 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

April 1, 2007

Primary Completion (ACTUAL)

April 1, 2008

Study Completion (ACTUAL)

June 1, 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

  • P05710
  • 2006-003812-23 (EUDRACT_NUMBER)
  • 107014 (OTHER: Organon)
  • MK-8962-003 (OTHER: Merck)

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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