Frozen-thawed Embryo Transfer (FTET) Cycle Follow-up Protocol (P06031)

Infertility Clinical Trial

Official title:

Follow-up Protocol to Collect the Outcome and Safety of Frozen-thawed Embryo Transfer (FTET) Cycles After Cryopreservation of Embryos in Clinical Study P06029 (Phase 3; Protocol No. P06031)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01146418
• Other study ID #: P06031
• Status: Completed
• Phase: Phase 3
• Start date: June 2, 2010
• Est. completion date: April 29, 2014

Study information

• Verified date: February 2022
• Source: Organon and Co
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this follow-up study is to collect the outcome and safety of FTET cycles after the embryos are cryopreserved in P06029 (NCT01144416). P06029 was a study in which a single injection of corifollitropin alfa (SCH 900962) was compared with daily recombinant follicle stimulating hormone (recFSH) injections in women aged 35 to 42 years undergoing controlled ovarian stimulation (COS) prior to in vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 307
• Est. completion date: April 29, 2014
• Est. primary completion date: July 24, 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 35 Years to 42 Years

Eligibility

Inclusion Criteria:

• Participant must have provided written informed consent for the trial.
• Participant must have cryopreserved embryo(s) in trial P06029 (NCT01144416) of which at least one embryo is thawed for use in a subsequent FTET cycle.

Related Conditions & MeSH terms

• Infertility

Intervention

Biological:
• Corifollitropin alfa
Single injection of 150 µg corifollitropin alfa administered under protocol P06029
• recFSH (follitropin beta)
Daily recFSH 300 IU administered under protocol P06029.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Organon and Co

References & Publications (1)

Boostanfar R, Gates D, Guan Y, Gordon K, McCrary Sisk C, Stegmann BJ. Efficacy and safety of frozen-thawed embryo transfer in women aged 35 to 42 years from the PURSUE randomized clinical trial. Fertil Steril. 2016 Aug;106(2):300-305.e5. doi: 10.1016/j.fe — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants With =1 Vital Pregnancy (Cumulative Vital Pregnancy Rate)	The cumulative vital pregnancy rate was defined as the number of participants with at least 1 vital pregnancy in a controlled ovarian stimulation (COS) cycle in Base Study P06029 or a frozen-thawed embryo transfer (FTET) in Follow Up Study P06031, divided by the total number of participants in each Full Analysis Set (FAS) treatment group. A vital pregnancy was defined as an intrauterine pregnancy with fetal heart tones assessed at least 35 days (=5 weeks) after embryo transfer (ET).	Assessed at least 35 days after ET in COS cycle in Base Study P06029 or an FTET cycle in Follow-Up Study P06031 (up to 2 years)
Secondary	Percentage of Participants With =1 Live Birth (Cumulative Live-Birth Rate)	The cumulative live-birth rate was defined as the number of participants with at least 1 live birth after ET in a COS cycle in Base Study P06029 or an FTET in Follow-Up Study P06031, divided by the total number of participants in each FAS treatment group.	From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to time of delivery (up to 2 years)