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

Pregnancy Clinical Trial

— Care  

Official title:

Pregnancy and Neonatal Follow-up of Ongoing Pregnancies Established After Controlled Ovarian Stimulation in Clinical Trial 38825 for Org 36286 (Corifollitropin Alfa)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00702234
• Other study ID #: P05715
• Secondary ID: 2004-004967-3038
• Status: Completed
• Start date: February 15, 2007
• Est. completion date: January 15, 2010

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 (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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 268
• Est. completion date: January 15, 2010
• Est. primary completion date: October 22, 2009
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 39 Years

Eligibility

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:

• None

Related Conditions & MeSH terms

• Neonates
• Pregnancy

Intervention

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.
• 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.
• (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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Organon and Co

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	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.	Up to approximately 32 months after first dose of corifollitropin alfa in base study P05714 (NCT00696878)
Primary	Number of Expectant Mothers Experiencing Adverse Events (AEs)	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.	From approximately 10 weeks after fresh ET in base study P05714 up to birth of infant (up to approximately 6 months)
Primary	Number of Expectant Mothers Experiencing Serious AEs (SAEs)	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.	From approximately 10 weeks after fresh ET in base study P05714 up to birth of infant (up to approximately 6 months)
Primary	Number of Live Born Infants Experiencing AEs	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.	Up to 12 weeks after birth
Primary	Number of Live Born Infants Experiencing SAEs	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.	Up to 12 weeks after birth