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

Pregnancy Clinical Trial

— Care  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00702520
• Other study ID #: P05783
• Secondary ID: 38834MK-8962-010
• Status: Completed
• Start date: April 1, 2006
• Est. completion date: January 15, 2008

Study information

• Verified date: February 2022
• Source: Organon and Co
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: January 15, 2008
• Est. primary completion date: November 7, 2007
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 39 Years

Eligibility

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

Related Conditions & MeSH terms

• Neonates
• Pregnancy

Intervention

Drug:
• Corifollitropin alpha (MK-8962, Org 36286) 100 ug
Subcutaneous administration of corifollitropin alpha at a dose of 100 ug
• Corifollitropin alpha (MK-8962, Org 36286) 150 ug
Subcutaneous administration of corifollitropin alpha at a dose of 150 ug
• 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.
• Human chorionic gonadotprophin (hCG).
HCG was administered as a single subcutaneous injection of 5,000 to 10,000 international units.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Organon and Co

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Up to 1 Year
Primary	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.	Up to 1 Year
Primary	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.	Up to 1 Year
Primary	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.	Up to 1 Year
Primary	Take-Home Baby Rate	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)