Follow-up Protocol on the Outcome of Frozen-thawed Embryo Transfer Cycles From Clinical Trial P05690 (P05711)
February 1, 2022 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 107012
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Observational
Enrollment (Actual)
102
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
14 years to 32 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Sampling Method
Non-Probability Sample
Study Population
Women from whom embryos have been cryopreserved in base study P05690
Description
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
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
- Observational Models: Other
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Corifollitropin alfa 100 μg
In follow-up study, no medication or investigational product was administered.
But in base study P05690 (NCT00702845), participants received single subcutaneous (SC) injection of corifollitropin alfa 100 μg (Org 36286) on Day 2 or 3 of the menstrual cycle and daily placebo-recombinant Follicle Stimulating Hormone (recFSH) injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants in base study P05690 also received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including Day of Human Chorion Gonadotropin (hCG) administration.
Participants also received Gonadotropin Releasing Hormone (GnRH) antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including the Day of hCG (10,000 or 5,000 IU/USP).
Participants also received progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on day of oocyte pick-up (OPU) and continuing for at least 6 weeks or up to menses.
|
Single injection of 100 μg corifollitropin alfa administered under protocol P05690
Other Names:
GnRH antagonist ganirelix administered SC at a dose of 0.25 mg/day under protocol P05690
hCG 5,000 IU or 10,000 IU administered SC under protocol P05690
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.
Placebo-recFSH at the equivalent volume of 150 IU/day administered under protocol P05690
Open-label recFSH up to a maximum dose of 200 IU/day, administered under protocol P0590
|
|
recFSH 150 IU
In this follow-up study, no medication or investigational product was administered.
However, in base study P05690 (NCT00702845), participants in the reference group received a single SC injection of placebo-corifollitropin alfa administered on Day 2 or 3 of the menstrual cycle and daily SC recFSH 150 IU injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants also received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including the day of hCG (10,000 or 5,000 IU/USP) administration.
Participants also received the GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including the Day of hCG.
Participants also received progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on the day of OPU and continuing for at least 6 weeks or up to menses.
|
GnRH antagonist ganirelix administered SC at a dose of 0.25 mg/day under protocol P05690
hCG 5,000 IU or 10,000 IU administered SC under protocol P05690
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.
Open-label recFSH up to a maximum dose of 200 IU/day, administered under protocol P0590
Daily recFSH administered under protocol P05690
Other Names:
Single SC injection of placebo-corifollitropin alfa on Day 2 or 3 of the menstrual cycle, administered under protocol P05690
|
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 P05690 (NCT00702845), and FTET cycles in follow up study P05711
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Percentage of Participants in Follow up Study With a Miscarriage Per Clinical Pregnancy
Time Frame: After one or more FTET cycles, assessed at least 10 weeks after embryo transfer (up to 1 year)
|
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)
|
|
Percentage of Participants in Follow up Study With a Miscarriage Per Vital Pregnancy
Time Frame: After one or more FTET cycles, assessed at least 10 weeks after embryo transfer (up to 1 year)
|
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)
|
|
Percentage of Participants in Follow up Study With an Ecotopic 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 Study 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 Study 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 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
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
December 1, 2006
Primary Completion (Actual)
December 1, 2008
Study Completion (Actual)
December 1, 2008
Study Registration Dates
First Submitted
June 18, 2008
First Submitted That Met QC Criteria
June 18, 2008
First Posted (Estimate)
June 20, 2008
Study Record Updates
Last Update Posted (Actual)
February 3, 2022
Last Update Submitted That Met QC Criteria
February 1, 2022
Last Verified
February 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- P05711
- 2006-003813-42 (EudraCT Number)
- 107015 (Other Identifier: Organon)
- MK-8962-004 (Other Identifier: Merck)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.