NCT00702520 - Pregnancy and Neonatal Follow-up of Ongoing Pregnancies Established in Clinical Trial 38833 (P05783) | Crick

Overview

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.

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

15

Conditions

Pregnancy Neonates

Interventions

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

Subcutaneous administration of corifollitropin alpha at a dose of 100 ug

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

Subcutaneous administration of corifollitropin alpha at a dose of 150 ug

TriptorelinDRUG

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

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 39 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Number of Expectant Mothers Experiencing Adverse Events (AEs)

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.

Time frame: Up to 1 Year

Number of Expectant Mothers Experiencing Serious AEs (SAEs)

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.

Time frame: Up to 1 Year

Number of Infants Experiencing AEs

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.

Time frame: Up to 1 Year

Number of Infants Experiencing SAEs

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.