Follow-up Study of Frozen-thawed Embryo Transfer (FTET) Cycles After Cryopreservation of Embryos in Clinical Trial P05787 (P05716)

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 38819

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00702273
• Other study ID #: P05716
• Secondary ID: 2004-004773-2838
• Status: Completed
• Start date: April 19, 2006
• Est. completion date: May 31, 2009

Study information

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

Clinical Trial Summary

To collect the outcome of frozen-thawed embryo transfer cycles after the embryos are cryopreserved up to at least 1 year in Trial P05787 (NCT00696800), in order to estimate the cumulative pregnancy rate for each treatment group.

Description:

This is a follow-up protocol to collect the outcome of frozen-thawed embryo transfer cycles, performed after the embryos are cryopreserved up to at least 1 year in Trial P05787 (NCT00696800), to enable estimation of the cumulative pregnancy rate for each treatment group.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 344
• Est. completion date: May 31, 2009
• Est. primary completion date: May 19, 2009
• 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 Trial P05787 (NCT00696800), of which at least one embryo is thawed for use in a subsequent FTET cycle;

• Able and willing to give informed consent.

Exclusion Criteria:

• None

Related Conditions & MeSH terms

• In Vitro Fertilization

Intervention

Drug:
• 150 µg Corifollitropin Alfa
On the morning of day 2 or 3 of the menstrual cycle (Stimulation Day 1), a single SC injection of 150 µg (0.5 mL) Corifollitropin Alfa was administered in the abdominal wall.

Biological:
• 200 IU RecFSH/Follitropin beta (Days 1 to 7)
Daily SC injections with 200 IU fixed dose recFSH were started on Stimulation Day 1 and continued up to and including Stimulation Day 7.

Drug:
• Placebo for Corifollitropin Alfa
Pre-filled syringe containing an identical solution when compared to Corifollitropin Alfa. On the morning of day 2 or 3 of the menstrual cycle (Stimulation Day 1), a single SC injection was administered in the abdominal wall.
• Placebo for RecFSH/Follitropin beta
Identical ready-for-use solution, but without the active ingredient, supplied in cartridges for SC injection with the Follistim Pen. Daily SC injections were started on Stimulation Day 1 and continued up to and including Stimulation Day 7.

Biological:
• 200 IU RecFSH/Follitropin beta (Days 8 to hCG)
From Stimulation Day 8 onwards a daily SC dose of 200 IU recFSH was administered up to and including the Day of hCG.

Drug:
• Ganirelix
On Stimulation Day 5 a daily SC injection of 0.25 mg was started, which continued up to and including the day of hCG

Biological:
• hCG
When 3 follicles >= 17 mm were observed by USS, a single dose of 10,000 IU/USP hCG was administered; or, for those at risk for Ovarian Hyperstimulation Syndrome (OHSS), a lower dose of 5,000 IU/USP
• Progesterone
On the day of OPU, luteal phase support was started by administering micronized progesterone of at least 600 mg/day vaginally, or at least 50 mg/day intramuscular (IM), which continued for at least 6 weeks, or up to menses.

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)	An ongoing pregnancy is the presence of at least one fetus with heart activity at least 10 weeks after embryo transfer or confirmed by live birth.The cumulative ongoing pregnancy rate is 100 times the number of participants with an ongoing pregnancy either immediately after embryo transfer in base Trial P05787 (NCT00696800), or after one or more FTET cycles in follow-up Trial P05716 following cryopreservation, divided by the total number of participants that started treatment in base Trial P05787 (NCT00696800). Participants who did not have cryopreserved embryos, or embryo transfers in the FTET cycle(s), were considered 'not pregnant'.	Up to 1 year after embryo transfer in base trial P05787 (NCT00696800), and FTET cycles in follow up trial
Secondary	Percentage of Participants in Follow up Trial With a Miscarriage Per Clinical Pregnancy	Miscarriages were calculated per clinical pregnancy, meaning the presence of at least one gestational sac or confirmed by live birth.	After one or more FTET cycles, up to day of miscarriage (up to 1 year)
Secondary	Percentage of Participants in Follow up Trial With a Miscarriage Per Vital Pregnancy	Miscarriages were calculated per vital pregnancy, meaning the presence of at least one fetus with heart activity.	After one or more FTET cycles, up to day of miscarriage (up to 1 year)
Secondary	Percentage of Participants in Follow up Trial With an Ectopic 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 Trial 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 Trial 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 in Follow up Trial 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)