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Pregnancy and Neonatal Follow-up of Ongoing Pregnancies Established in Clinical Trial P05714 (Care Program)(P05715) (Care)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00702234
First Posted: June 20, 2008
Last Update Posted: April 18, 2017
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.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
  Purpose
The objective of this trial is to evaluate whether corifollitropin alfa (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. In addition, a primary efficacy variable, live birth rate, was evaluated.

Condition Intervention
Pregnancy Neonates Biological: Corifollitropin alfa Biological: GnRH antagonist Biological: (rec)hCG Biological: FSH Drug: Progesterone

Study Type: Observational
Study Design: Observational Model: Other
Time Perspective: Prospective
Official Title: Pregnancy and Neonatal Follow-up of Ongoing Pregnancies Established After Controlled Ovarian Stimulation in Clinical Trial 38825 for Org 36286 (Corifollitropin Alfa)

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

Primary Outcome Measures:
  • Percentage of Women With Ongoing Pregnancy After a Corifollitropin Alfa COS Cycle in Base Study and ≥1 Live Born Infant During Follow-up (Live Birth Rate) [ Time Frame: Up to approximately 32 months after first dose of corifollitropin alfa in base study P05714 (NCT00696878) ]
    The live birth rate was defined as the number of participants who had an ongoing pregnancy after a corifollitropin alfa COS cycle in base study P05714 (NCT00696878) and who had at least one live born infant during follow-up, divided by the number of participants treated in the base study. For this analysis, it was assumed that any participants with ongoing pregnancy after a COS cycle in base study who did not enroll in follow-up study P05715 had no live born infants.

  • Number of Expectant Mothers Experiencing Adverse Events (AEs) [ Time Frame: From approximately 10 weeks after fresh ET in base study P05714 up to birth of infant (up to approximately 6 months) ]
    An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.

  • Number of Expectant Mothers Experiencing Serious AEs (SAEs) [ Time Frame: From approximately 10 weeks after fresh ET in base study P05714 up to birth of infant (up to approximately 6 months) ]
    An SAE was defined as any untoward medical occurrence that at any dose resulted in death, was life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, or was a congenital anomaly/birth defect.

  • Number of Live Born Infants Experiencing AEs [ Time Frame: Up to 12 weeks after birth ]
    An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.

  • Number of Live Born Infants Experiencing SAEs [ Time Frame: Up to 12 weeks after birth ]
    An SAE was defined as any untoward medical occurrence that at any dose resulted in death, was life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, or was a congenital anomaly/birth defect.


Enrollment: 268
Actual Study Start Date: February 15, 2007
Study Completion Date: January 15, 2010
Primary Completion Date: October 22, 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Women/Expectant Mothers - Corifollitropin Alfa 150 µg
In base study P05714 (NCT00696878), up to 3 COS cycles were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of Gonadotropin Releasing Hormone (GnRH) antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of recombinant Human Chorion Gonadotropin ([rec]hCG) (5,000-10,000 IU/250 µg). Daily dosing with Follicle Stimulating Hormone (FSH) (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, Frozen-Thawed Embryo Transfer cycles (up to 3 after each COS cycle) could occur. Participants with confirmed pregnancy at least 10 weeks after fresh embryo transfer in the base study were eligible for this follow-up study. In this follow-up study P05715, no study drugs were administered.
Biological: Corifollitropin alfa
Subcutaneous (SC) administration of corifollitropin alfa at a dose of 150 μg in base study P05714 (NCT00696878). In this follow-up study P05715, no study medications were administered.
Other Names:
  • Org 36286
  • SCH 900962
  • MK-8962
Biological: GnRH antagonist
SC administration of a GnRH antagonist at a dose of 0.25 mg/day in base study P05714 (NCT00696878). In this follow-up study P05715, no study medications were administered.
Biological: (rec)hCG
SC administration of (rec)hCG at a dose of 5,000-10,000 IU/250 µg in base study P05714 (NCT00696878). In this follow-up study P05715, no study medications were administered.
Biological: FSH
SC administration of FSH at a dose not to exceed 225 IU/day in base study P05714 (NCT00696878). In this follow-up study P05715, no study medications were administered.
Drug: Progesterone
Vaginal administration of progesterone at a dose of at least 600 mg/day in base study P05714 (NCT00696878). In this follow-up study P05715, no study medications were administered.

Detailed Description:
This is a follow-up protocol to prospectively monitor pregnancy, delivery, and neonatal outcomes of women who were treated with corifollitropin alfa and became pregnant after fresh embryo transfer during the base study P05714 (NCT00696878). For this trial, no study specific assessments are required, but information as obtained in standard practice will be used.
  Eligibility

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 fresh embryo transfer in base study P05714 (NCT00696878) were enrolled in this trial.
Criteria

Inclusion Criteria:

  • Participants who participated in base study P05714 (NCT00696878) and received at least one dose of corifollitropin alfa in base study P05714;
  • Ongoing pregnancy confirmed by ultrasound at least 10 weeks after a fresh embryo transfer in base study P05714;
  • Able and willing to give written informed consent.

Exclusion Criteria:

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00702234


Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Director Merck Sharp & Dohme Corp.
  More Information

Study Data/Documents: CSR Synopsis  This link exits the ClinicalTrials.gov site

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00702234     History of Changes
Other Study ID Numbers: P05715
2004-004967-30 ( EudraCT Number )
38829 ( Other Identifier: Organon )
MK-8962-008 ( Other Identifier: Merck )
First Submitted: June 18, 2008
First Posted: June 20, 2008
Results First Submitted: April 9, 2015
Results First Posted: April 27, 2015
Last Update Posted: April 18, 2017
Last Verified: March 2017

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

Additional relevant MeSH terms:
Progesterone
Progestins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs