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

Pregnancy Clinical Trial

— Care  

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00702624
• Other study ID #: P05710
• Secondary ID: 2006-003812-2310
• Status: Completed
• Start date: April 2007
• Est. completion date: June 2008

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 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 113
• Est. completion date: June 2008
• Est. primary completion date: April 2008
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 36 Years

Eligibility

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

Related Conditions & MeSH terms

• Neonates
• Pregnancy

Intervention

Drug:
• Corifollitropin alfa
Single injection of 100 µg corifollitropin alfa administered under protocol P05690

Biological:
• recFSH (follitropin beta)
Daily recFSH administered under protocol P05690

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
• 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
• 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

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 =1 Live Born Infant During Follow-up (Take-Home Baby Rate)	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.	From approximately 10 weeks after ET in base study P05690 up to birth of infant (up to approximately 6 months)
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 ET in base study P05690 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 ET in base study P05690 up to birth of infant (up to approximately 6 months)
Primary	Number of 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 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.	Up to 12 weeks after birth
Primary	Number of 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