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Completed

NCT Number: NCT00702520

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

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.

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Key information

Conditions

Pregnancy Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Neonates

Age range

18 year–39 year

Sex eligibility

Female

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Corifollitropin alpha (MK-8962, Org 36286) 100 ug

Drug

Subcutaneous administration of corifollitropin alpha at a dose of 100 ug

Corifollitropin alpha (MK-8962, Org 36286) 150 ug

Drug

Subcutaneous administration of corifollitropin alpha at a dose of 150 ug

Triptorelin

Drug

Daily SC injections of 0.1 mg triptorelin started between Day 21 and 24 of the menstrual cycle (mid luteal phase).

recombinant Follicle Stimulating Hormone (recFSH)

Biological

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.

Human chorionic gonadotprophin (hCG).

Biological

HCG was administered as a single subcutaneous injection of 5,000 to 10,000 international units.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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).

Sponsors and collaborators

Lead sponsor

Organon and Co

Industry

Registry information

Official study title

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

Acronym: Care

Important dates

Study start
2006
Primary completion
2007
Study completion
2008
First posted
Jun 20, 2008
Registry last updated
Sep 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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