Follow-up Study of Frozen-thawed Embryo Transfer (FTET) Cycles After Cryopreservation of Embryos in Clinical Trial P05787 (P05716)
Follow-up Protocol to Collect the Outcome of Frozen-thawed Embryo Transfer Cycles After Cryopreservation of Embryos in Clinical Trial 38819
4 other identifiers
observational
344
0 countries
N/A
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Apr 2006
Typical duration for all trials
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 19, 2006
CompletedFirst Submitted
Initial submission to the registry
June 18, 2008
CompletedFirst Posted
Study publicly available on registry
June 20, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 19, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
May 31, 2009
CompletedResults Posted
Study results publicly available
November 20, 2014
CompletedSeptember 5, 2024
February 1, 2022
3.1 years
June 18, 2008
May 14, 2014
August 13, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (6)
Percentage of Participants in Follow up Trial With a Miscarriage Per Clinical Pregnancy
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
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
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
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
After one or more FTET cycles, assessed at least 10 weeks after embryo transfer (up to 1 year)
- +1 more secondary outcomes
Study Arms (2)
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.
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.
Interventions
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.
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.
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.
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.
Eligibility Criteria
Women from whom embryos have been cryopreserved in Base Trial P05787 (NCT00696800).
You may qualify if:
- 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.
You may not qualify if:
- None
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Organon and Colead
Related Publications (1)
Boostanfar R, Mannaerts B, Pang S, Fernandez-Sanchez M, Witjes H, Devroey P; Engage Investigators. A comparison of live birth rates and cumulative ongoing pregnancy rates between Europe and North America after ovarian stimulation with corifollitropin alfa or recombinant follicle-stimulating hormone. Fertil Steril. 2012 Jun;97(6):1351-8. doi: 10.1016/j.fertnstert.2012.02.038. Epub 2012 Mar 28.
PMID: 22459628DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Senior Vice President, Global Clinical Development
- Organization
- Merck Sharp & Dohme Corp.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 18, 2008
First Posted
June 20, 2008
Study Start
April 19, 2006
Primary Completion
May 19, 2009
Study Completion
May 31, 2009
Last Updated
September 5, 2024
Results First Posted
November 20, 2014
Record last verified: 2022-02