Pregnancy and Neonatal Follow-up of Ongoing Pregnancies Established in Clinical Trial P05690 (Care Program) (P05710)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00702624
First received: June 18, 2008
Last updated: April 13, 2015
Last verified: April 2015
  Purpose

The objective of this follow-up study 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.


Condition Intervention
Pregnancy
Neonates
Drug: Corifollitropin alfa
Biological: recFSH (follitropin beta)
Drug: gonadatropin releasing hormone (GnRH) antagonist ganirelix
Biological: human chorion gonadotropin (hCG)
Biological: progesterone
Drug: placebo-recFSH (follitropin beta)
Drug: placebo-corifollitropin alfa
Biological: open-label recFSH (follitropin beta)

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 107012 for the Development of Org 36286 (Corifollitropin Alfa)

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Percentage of Women With ≥1 Live Born Infant During Follow-up (Take-Home Baby Rate) [ Time Frame: From approximately 10 weeks after ET in base study P05690 up to birth of infant (up to approximately 6 months) ] [ Designated as safety issue: No ]
    The Take-Home Baby Rate was defined as the number of participants with an ongoing pregnancy in base study P05690 with at least one live born infant during follow up relative to the number of participants treated in base study.

  • Number of Expectant Mothers Experiencing Adverse Events (AEs) [ Time Frame: From approximately 10 weeks after ET in base study P05690 up to birth of infant (up to approximately 6 months) ] [ Designated as safety issue: Yes ]
    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 ET in base study P05690 up to birth of infant (up to approximately 6 months) ] [ Designated as safety issue: Yes ]
    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 Infants Experiencing AEs [ Time Frame: Up to 12 weeks after birth ] [ Designated as safety issue: Yes ]
    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 can 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 Infants Experiencing SAEs [ Time Frame: Up to 12 weeks after birth ] [ Designated as safety issue: Yes ]
    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: 113
Study Start Date: April 2007
Study Completion Date: June 2008
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Corifollitropin alfa 100 μg
In follow-up study, no medication or investigational product was administered. In base study P05690 (NCT00702845), participants received single subcutaneous (SC) injection of corifollitropin alfa 100 μg (Org 36286) on Day 2 or 3 of menstrual cycle and daily placebo-recombinant Follicle Stimulating Hormone (recFSH) injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants in base study P05690 also received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including Day of Human Chorion Gonadotropin (hCG) administration. Participants also received Gonadotropin Releasing Hormone (GnRH) antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including Day of hCG (10,000 or 5,000 IU/USP). Participants also received progesterone (at least 600 mg/day vaginally or 50 mg/day by intramuscular [IM] injection), starting on day of oocyte pick-up (OPU) and continuing for at least 6 weeks or up to menses.
Drug: Corifollitropin alfa
Single injection of 100 μg corifollitropin alfa administered under protocol P05690
Other Names:
  • SCH 900962
  • MK-8962
Drug: gonadatropin releasing hormone (GnRH) antagonist ganirelix
GnRH antagonist ganirelix administered SC at a dose of 0.25 mg/day under protocol P05690
Biological: human chorion gonadotropin (hCG)
hCG 5,000 IU/USP or 10,000 IU/USP administered under protocol P05690
Biological: progesterone
Under protocol P05690, progesterone was started on the day of oocyte pick-up (OPU) and continued for at least 6 weeks or up to menses. Participants received at least 600 mg/day vaginally or 50 mg/day IM.
Drug: placebo-recFSH (follitropin beta)
Placebo-recFSH at the equivalent volume of 150 IU/day administered under protocol P05690
Biological: open-label recFSH (follitropin beta)
Open-label recFSH up to a maximum dose of 200 IU/day, administered under protocol P05690
recFSH 150 IU
In follow-up study, no medication or investigational product was administered. In base study P05690 (NCT00702845), participants in the reference group received a single SC injection of placebo-corifollitropin alfa administered on Day 2 or 3 of the menstrual cycle and daily SC recFSH 150 IU injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants also received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including Day of hCG (10,000 or 5,000 IU/USP) administration. Participants also received the GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including the Day of hCG. Participants also received progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on the day of OPU and continuing for at least 6 weeks or up to menses.
Biological: recFSH (follitropin beta)
Daily recFSH administered under protocol P05690
Other Names:
  • follitropin beta
  • Puregon®
  • Follistim®
Drug: gonadatropin releasing hormone (GnRH) antagonist ganirelix
GnRH antagonist ganirelix administered SC at a dose of 0.25 mg/day under protocol P05690
Biological: human chorion gonadotropin (hCG)
hCG 5,000 IU/USP or 10,000 IU/USP administered under protocol P05690
Biological: progesterone
Under protocol P05690, progesterone was started on the day of oocyte pick-up (OPU) and continued for at least 6 weeks or up to menses. Participants received at least 600 mg/day vaginally or 50 mg/day IM.
Drug: placebo-corifollitropin alfa
Single SC injection of placebo-corifollitropin alfa on Day 2 or 3 of the menstrual cycle, administered under protocol P05690
Biological: open-label recFSH (follitropin beta)
Open-label recFSH up to a maximum dose of 200 IU/day, administered under protocol P05690

Detailed Description:

This is a follow-up protocol to prospectively monitor pregnancy, delivery, and neonatal outcome of women who were treated with corifollitropin alfa or recFSH and became pregnant during the base study P05690 (NCT00702845). For this trial no study specific assessments are required, but information as obtained in standard practice will be used.

  Eligibility

Ages Eligible for Study:   18 Years to 36 Years
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 base study P05690 (NCT00702845) were enrolled in this trial.

Criteria

Inclusion Criteria:

  • Participants who participated in base study P05690 (NCT00702845) and received at least one dose of either corifollitropin alfa (Org 36286) or recFSH in base study P05690;
  • Ongoing pregnancy confirmed by ultrasound at least 10 weeks after embryo transfer in base study P05690;
  • Able and willing to give written informed consent.

Exclusion Criteria:

  • None
  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.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00702624

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

No publications provided by Merck Sharp & Dohme Corp.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00702624     History of Changes
Other Study ID Numbers: P05710, 2006-003812-23, 107014, MK-8962-003
Study First Received: June 18, 2008
Results First Received: April 13, 2015
Last Updated: April 13, 2015
Health Authority: Austria: Federal Office for Safety in Health Care
Czech Republic: State Institute for Drug Control
Denmark: Danish Medicines Agency
Spain: Ministry of Health and Consumption
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Sweden: Medical Products Agency

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

Additional relevant MeSH terms:
Follicle Stimulating Hormone
Ganirelix
Hormones
Progesterone
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Pharmacologic Actions
Physiological Effects of Drugs
Progestins

ClinicalTrials.gov processed this record on July 29, 2015