Follow-up Protocol on the Outcome of Frozen-thawed Embryo Transfer Cycles From Clinical Trial P05690 (P05711)

In Vitro Fertilization Clinical Trial

Official title:

Follow-up Protocol to Collect the Outcome of Frozen-thawed Embryo Transfer Cycles After Cryopreservation of Embryos in Clinical Trial 107012

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00702546
• Other study ID #: P05711
• Secondary ID: 2006-003813-4210
• Status: Completed
• Start date: December 2006
• Est. completion date: December 2008

Study information

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

Clinical Trial Summary

Clinical trial objective is to collect the outcome of Frozen-Thawed Embryo Transfer (FTET) cycles performed after the embryos are cryopreserved in the base study P05690 in order to estimate the cumulative pregnancy rate for each treatment group.

Description:

This is a follow-up protocol to collect the outcome of FTET cycles, performed after the embryos are cryopreserved in base study P05690 (NCT00702845), to enable estimation of the cumulative pregnancy rate for each treatment group.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 102
• Est. completion date: December 2008
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 36 Years

Eligibility

Inclusion Criteria:

• Participants from whom embryos have been cryopreserved in base study P05690, of which at least one embryo is thawed for use in a subsequent FTET cycle;
• Able and willing to give written informed consent.

Exclusion Criteria:

• None

Related Conditions & MeSH terms

• In Vitro Fertilization

Intervention

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

Biological:
• recFSH (follitropin alfa)
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
• human chorion gonadatropin (hCG)
hCG 5,000 IU or 10,000 IU administered SC 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 alfa)
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
Open-label recFSH up to a maximum dose of 200 IU/day, administered under protocol P0590

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 Participants With an Ongoing Pregnancy (Cumulative Ongoing Pregnancy Rate)	Cumulative ongoing pregnancy rate was defined as 100 times the number of participants with an ongoing pregnancy either immediately after embryo transfer in base study P05690 (NCT00702845) or after one or more FTET cycles in follow up study P05711 following cryopreservation, divided by the total number of subjects that started treatment in base study P05690.	Up to 1 year after embryo transfer in base trial P05690 (NCT00702845), and FTET cycles in follow up study P05711
Secondary	Percentage of Participants in Follow up Study With a Miscarriage Per Clinical Pregnancy	Miscarriages were calculated per clinical pregnancy, defined as the presence of at least one gestational sac as assessed by USS or Doppler, or confirmed by live birth.	After one or more FTET cycles, assessed at least 10 weeks after embryo transfer (up to 1 year)
Secondary	Percentage of Participants in Follow up Study With a Miscarriage Per Vital Pregnancy	Miscarriages were calculated per vital pregnancy, defined as the presence of at least one fetus with heart activity as assessed by USS or Doppler, or confirmed by live birth.	After one or more FTET cycles, assessed at least 10 weeks after embryo transfer (up to 1 year)
Secondary	Percentage of Participants in Follow up Study With an Ecotopic Pregnancy	An ectopic pregnancy is where the embryo implants outside the uterus. Ectopic pregnancies were calculated per total number of participants started in FTET.	After one or more FTET cycles, assessed at least 10 weeks after embryo transfer (up to 1 year)
Secondary	Percentage of Participants in Follow up Study With a Clinical Pregnancy	A clinical pregnancy is the presence of at least gestational sac or confirmed by live birth. Clinical pregnancies were calculated per attempt, meaning if any stage of in vitro fertilization (IVF) treatment was not achieved, zero values were imputed.	After one or more FTET cycles, assessed at least 10 weeks after embryo transfer (up to 1 year)
Secondary	Percentage of Participants in Follow up Study With a Vital Pregnancy	A vital pregnancy is the presence of at least one fetus with heart activity. Vital pregnancies were calculated per attempt, meaning if any stage of IVF treatment was not achieved, zero values were imputed.	After one or more FTET cycles, assessed at least 10 weeks after embryo transfer (up to 1 year)
Secondary	Percentage of Participants With an Ongoing Pregnancy	An ongoing pregnancy is the presence of at least one fetus with heart activity at least 10 weeks after embryo transfer or confirmed at live birth. Ongoing pregnancies were calculated per attempt, meaning if any stage of IVF treatment was not achieved, zero values were imputed.	After one or more FTET, assessed at least 10 weeks after embryo transfer or at live birth (up to 1 year)