Clinical trial NCT00702273: Follow-up Study of Frozen-thawed Embryo Transfer (FTET) Cycles After Cryopreservation of Embryos in Clinical Trial P05787 (P05716)
Official title: Follow-up Protocol to Collect the Outcome of Frozen-thawed Embryo Transfer Cycles After Cryopreservation of Embryos in Clinical Trial 38819
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: In Vitro Fertilization
Keywords: In-vitro fertilization
Controlled Ovarian Stimulation
Cumulative pregnancy data
Follow-up
Lead sponsor: Organon and Co
Sponsor class: INDUSTRY
First posted: 2008-06-20
Enrollment: 344
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 36
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Women from whom embryos have been cryopreserved in Base Trial P05787 (NCT00696800).

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Percentage of Participants With an Ongoing Pregnancy (Cumulative Ongoing Pregnancy Rate)
timeFrame: Up to 1 year after embryo transfer in base trial P05787 (NCT00696800), and FTET cycles in follow up trial
Secondary outcomes:
measure: Percentage of Participants in Follow up Trial With a Miscarriage Per Clinical Pregnancy
timeFrame: After one or more FTET cycles, up to day of miscarriage (up to 1 year)
measure: Percentage of Participants in Follow up Trial With a Miscarriage Per Vital Pregnancy
timeFrame: After one or more FTET cycles, up to day of miscarriage (up to 1 year)
measure: Percentage of Participants in Follow up Trial With an Ectopic Pregnancy
timeFrame: After one or more FTET cycles, assessed at least 10 weeks after embryo transfer (up to 1 year)
measure: Percentage of Participants in Follow up Trial With a Clinical Pregnancy
timeFrame: After one or more FTET cycles, assessed at least 10 weeks after embryo transfer (up to 1 year)
measure: Percentage of Participants in Follow up Trial With a Vital Pregnancy
timeFrame: After one or more FTET cycles, assessed at least 10 weeks after embryo transfer (up to 1 year)
measure: Percentage of Participants in Follow up Trial With an Ongoing Pregnancy
timeFrame: After one or more FTET, assessed at least 10 weeks after embryo transfer or at live birth (up to 1 year)
Other outcomes:
Locations:
Study officials:
References:
citation: 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.