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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00702520
First received: June 18, 2008
Last updated: December 3, 2014
Last verified: December 2014
History of Changes
  Purpose
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.

Condition Intervention
Pregnancy
Neonates
 Drug: Corifollitropin alpha (MK-8962, Org 36286) 100 ug
Drug: Corifollitropin alpha (MK-8962, Org 36286) 150 ug
Drug: Triptorelin
Biological: Recombinant follicle stimulating hormone (recFSH)
Biological: Human chorionic gonadotprophin (hCG).

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Pregnancy and Neonatal Follow-up of Ongoing Pregnancies Established After Controlled Ovarian Stimulation in Clinical Trial 38833 for Org 36286 (Corifollitropin Alfa)

Resource links provided by NLM:

MedlinePlus related topics: Hormones
U.S. FDA Resources

Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Number of Expectant Mothers Experiencing Adverse Events (AEs) [ Time Frame: Up to 1 Year ] [ Designated as safety issue: Yes ]
    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.

  • Number of Expectant Mothers Experiencing Serious AEs (SAEs) [ Time Frame: Up to 1 Year ] [ Designated as safety issue: Yes ]
    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.

  • Number of Infants Experiencing AEs [ Time Frame: Up to 1 Year ] [ Designated as safety issue: Yes ]
    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.

  • Number of Infants Experiencing SAEs [ Time Frame: Up to 1 Year ] [ Designated as safety issue: Yes ]
    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.

  • Take-Home Baby Rate [ Time Frame: Birth of a one or more live babies (Up to 1 year) ] [ Designated as safety issue: No ]
    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).
Enrollment: 15
Study Start Date: April 2006
Study Completion Date: January 2008
Primary Completion Date: November 2007 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Corifollitropin alpha 100 ug
In the base study (P05788, 38833, NCT00702351), participants were pre-treated with daily subcutaneous (SC) injections of 0.1 mg triptorelin started between Day 21 and 24 of the menstrual cycle (mid luteal phase). After suppression of endogenous luteinizing hormone (LH) and follicle stimulating hormone (FSH) was confirmed by estradiol (E2) and progesterone (P) measurements, a single dose of corifollitropin alpha 100 μg was administered in participants weighing <= 60 kg. From stimulation Day 8 onwards, treatment was continued with daily SC of recombinant follicle stimulating hormone (recFSH) injections (maximally 200 IU) up to and including the day of administration of human chorionic gonadotprophin (hCG). No study medications were administered in the present P05783 study (38834, NCT00702520).
 Drug: Corifollitropin alpha (MK-8962, Org 36286) 100 ug
Subcutaneous administration of corifollitropin alpha at a dose of 100 ug
Drug: 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.
Biological: Human chorionic gonadotprophin (hCG).
HCG was administered as a single subcutaneous injection of 5,000 to 10,000 international units.
Corifollitropin alpha 150 ug
In the base study (P05788, 38833, NCT00702351), participants were pre-treated with daily SC injections of 0.1 mg triptorelin started between Day 21 and 24 of the menstrual cycle (mid luteal phase). After suppression of endogenous LH and FSH was confirmed by E2 and P measurements, a single dose of corifollitropin alpha 150 μg was administered in participants weighing >= 50 kg. 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. No study medications were administered in the present P05783 study (38834, NCT00702520).
 Drug: Corifollitropin alpha (MK-8962, Org 36286) 150 ug
Subcutaneous administration of corifollitropin alpha at a dose of 150 ug
Drug: 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.
Biological: Human chorionic gonadotprophin (hCG).
HCG was administered as a single subcutaneous injection of 5,000 to 10,000 international units.

Detailed 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.
  Eligibility
Ages Eligible for Study:   18 Years to 39 Years   (Adult)
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Women with an ongoing pregnancy at least 10 weeks after embryo transfer in Trial 38833 were enrolled in this trial.
Criteria

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:

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00702520     History of Changes
Other Study ID Numbers: P05783  38834  MK-8962-010  2005-000062-40 
Study First Received: June 18, 2008
Results First Received: May 20, 2014
Last Updated: December 3, 2014
Health Authority: Belgium: Federal Agency for Medicinal Products and Health Products

Keywords provided by Merck Sharp & Dohme Corp.:
Neonatal outcome
Congenital malformations
In-Vitro fertilization
Controlled ovarian stimulation
Follow-up

Additional relevant MeSH terms:
Hormones
Follicle Stimulating Hormone
Triptorelin Pamoate
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Luteolytic Agents
 Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Antineoplastic Agents, Hormonal
Antineoplastic Agents

ClinicalTrials.gov processed this record on September 28, 2016