Follow-up Study of Frozen-thawed Embryo Transfer (FTET) Cycles After Cryopreservation of Embryos in Clinical Trial P05787 (P05716)
August 13, 2024 updated by: Organon and Co
Follow-up Protocol to Collect the Outcome of Frozen-thawed Embryo Transfer Cycles After Cryopreservation of Embryos in Clinical Trial 38819
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Observational
Enrollment (Actual)
344
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 36 years (Adult)
Accepts Healthy Volunteers
No
Sampling Method
Probability Sample
Study Population
Women from whom embryos have been cryopreserved in Base Trial P05787 (NCT00696800).
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
150 µg Corifollitropin Alfa
Participants from the base study P05787 (NCT00696800), received a single subcutaneous (SC) injection of 150 µg Corifollitropin Alfa (Org 36286) on menstrual cycle Day 2/3 (Day 1); 7 daily SC injections from Days 1 to 7 with placebo-recombinant Follicle Stimulating Hormone (recFSH); followed by daily SC injections with 200 IU recFSH up to the day of human chorionogonadotropin (hCG).
Daily SC injections of Ganirelix were given from Day 5 to the day of hCG; at which time a single dose of hCG was given when 3 follicles >= 17 mm.
On the day of oocyte pick up (OPU) daily doses of progesterone were started, for up to 6 weeks or menses.
Eligible participants from the base study were enrolled in follow up study P05716, where no study treatments were given, and embryos obtained in the base study underwent FTET cycles.
|
On Stimulation Day 5 a daily SC injection of 0.25 mg was started, which continued up to and including the day of 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
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.
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.
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.
From Stimulation Day 8 onwards a daily SC dose of 200 IU recFSH was administered up to and including the Day of hCG.
|
|
200 IU RecFSH
Participants from the base study P05787 (NCT00696800), received a single SC injection of placebo Corifollitropin Alfa on menstrual cycle day 2/3 (Day 1); 7 daily SC injections with 200 IU recFSH from Days 1 to 7; followed by daily SC injections with 200 IU recFSH up to the day of hCG.
Multiple daily SC injections of Ganirelix were given from Day 5 to the day of hCG; at which time a single dose of hCG was given when 3 follicles >= 17 mm.
On the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses.
Eligible participants from the base study were enrolled in follow up study P05716, where no study treatments were given, and embryos obtained in the base study underwent FTET cycles.
|
On Stimulation Day 5 a daily SC injection of 0.25 mg was started, which continued up to and including the day of 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
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.
From Stimulation Day 8 onwards a daily SC dose of 200 IU recFSH was administered up to and including the Day of hCG.
Daily SC injections with 200 IU fixed dose recFSH were started on Stimulation Day 1 and continued up to and including Stimulation Day 7.
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Percentage of Participants With an Ongoing Pregnancy (Cumulative Ongoing Pregnancy Rate)
Time Frame: Up to 1 year after embryo transfer in base trial P05787 (NCT00696800), and FTET cycles in follow up trial
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Percentage of Participants in Follow up Trial With a Miscarriage Per Clinical Pregnancy
Time Frame: After one or more FTET cycles, up to day of miscarriage (up to 1 year)
|
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)
|
|
Percentage of Participants in Follow up Trial With a Miscarriage Per Vital Pregnancy
Time Frame: After one or more FTET cycles, up to day of miscarriage (up to 1 year)
|
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)
|
|
Percentage of Participants in Follow up Trial With an Ectopic Pregnancy
Time Frame: After one or more FTET cycles, assessed at least 10 weeks after embryo transfer (up to 1 year)
|
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)
|
|
Percentage of Participants in Follow up Trial With a Clinical Pregnancy
Time Frame: After one or more FTET cycles, assessed at least 10 weeks after embryo transfer (up to 1 year)
|
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)
|
|
Percentage of Participants in Follow up Trial With a Vital Pregnancy
Time Frame: After one or more FTET cycles, assessed at least 10 weeks after embryo transfer (up to 1 year)
|
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)
|
|
Percentage of Participants in Follow up Trial With an Ongoing Pregnancy
Time Frame: After one or more FTET, assessed at least 10 weeks after embryo transfer or at live birth (up to 1 year)
|
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)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
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Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 19, 2006
Primary Completion (Actual)
May 19, 2009
Study Completion (Actual)
May 31, 2009
Study Registration Dates
First Submitted
June 18, 2008
First Submitted That Met QC Criteria
June 19, 2008
First Posted (Estimated)
June 20, 2008
Study Record Updates
Last Update Posted (Actual)
September 5, 2024
Last Update Submitted That Met QC Criteria
August 13, 2024
Last Verified
February 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- P05716
- 38831 (Organon)
- 2004-004773-28 (EudraCT Number)
- MK-8962-009 (Other Identifier: Merck)
Plan for Individual participant data (IPD)
Study Data/Documents
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