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Pregnancy & Neonatal Follow-up of Ongoing Pregnancies Established During Clinical Trial 38826 (Study 38827)(P06056)(COMPLETED)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00702988
Recruitment Status : Completed
First Posted : June 20, 2008
Last Update Posted : June 23, 2017
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Brief Summary:
The objective of this trial was to evaluate whether Org 36286 treatment for the induction of multifollicular growth in women undergoing controlled ovarian stimulation (COS) for in vitro fertilization (IVF) or intracytoplasmatic sperm injection (ICSI) is safe for pregnant subjects and their offspring.

Condition or disease Intervention/treatment
Pregnancy Neonates Drug: Org 36286 Drug: recFSH

Detailed Description:
This was an open, prospective follow-up trial to monitor pregnancy, delivery, and neonatal outcome of women who became pregnant during Trial 38826. For this trial, no study specific assessments were required, but information obtained in standard practice was used.

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Study Type : Observational
Actual Enrollment : 44 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Pregnancy and Neonatal Follow-up of Ongoing Pregnancies Established During Clinical Trial 38826 for the Development of Org 36286 (Corifollitropin Alfa).
Actual Study Start Date : October 1, 2003
Actual Primary Completion Date : February 28, 2005
Actual Study Completion Date : February 28, 2005

Group/Cohort Intervention/treatment
Experimental Group 1
all doses of Org 36286 (corifollitropin alfa) (60 μg, 120 μg and 180 μg)
Drug: Org 36286
single dose of 60, 120, or 180 μg Org 36286 (experimental group administered under protocol 38826)
Other Name: Corifollitropin alfa

Experimental Group 2
150 IU recFSH
Drug: recFSH
150 IU recFSH daily (reference group administered under protocol 38826)
Other Name: Follitropin Beta, Puregon®, Follistim®

Primary Outcome Measures :
  1. Pregnancy status at 20 weeks of gestation [ Time Frame: one pregnancy period ]
  2. Take-home baby rate [ Time Frame: one pregnancy period ]

Secondary Outcome Measures :
  1. Pregnancy follow-up [ Time Frame: one pregnancy period ]
  2. Delivery follow-up [ Time Frame: one pregnancy period ]
  3. Neonatal outcome [ Time Frame: one pregnancy period ]
  4. Infant follow-up [ Time Frame: one pregnancy period ]
  5. Congenital malformations and chromosomal abnormalities [ Time Frame: one pregnancy period ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 39 Years   (Adult)
Sexes 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 38826 were enrolled in this trial.

Inclusion Criteria:

  • Subjects who participated in Trial 38826 and became pregnant (as confirmed by USS at or beyond 10 weeks after ET) after having received at least one dose of either Org 36286 or Puregon®; and
  • Able and willing to give written informed consent.

Exclusion Criteria:

  • None

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Merck Sharp & Dohme Corp. Identifier: NCT00702988     History of Changes
Other Study ID Numbers: P06056
First Posted: June 20, 2008    Key Record Dates
Last Update Posted: June 23, 2017
Last Verified: June 2017
Keywords provided by Merck Sharp & Dohme Corp.:
Neonatal outcome
Congenital malformations
In-Vitro Fertilization
Controlled ovarian stimulation