Trial · Observational
CompletedPhase not statedResults postedRegistry data1 trial · 1 completed · 1 with posted results
Follow-up Study of Frozen-thawed Embryo Transfer (FTET) Cycles After Cryopreservation of Embryos in Clinical Trial P05787 (P05716)
NCT0070227319 Apr 2006 to 31 May 2009
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
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.
Other
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.
Other
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.
Outcomes the sponsor listed as primary.
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'.
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.
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.
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.
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.
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.
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.
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
| Group | Value (Percentage of participants) |
|---|---|
| 150 µg Corifollitropin Alfa | 47.2 |
| 200 IU RecFSH | 44.9 |
| Group | Value (Percentage of participants) |
|---|---|
| 150 µg Corifollitropin Alfa | 8.2 |
| 200 IU RecFSH | 17.6 |
| Group | Value (Percentage of participants) |
|---|---|
| 150 µg Corifollitropin Alfa | 0 |
| 200 IU RecFSH | 0 |
| Group | Value (Percentage of participants) |
|---|---|
| 150 µg Corifollitropin Alfa | 1.2 |
| 200 IU RecFSH | 0.6 |
| Group | Value (Percentage of participants) |
|---|---|
| 150 µg Corifollitropin Alfa | 43.5 |
| 200 IU RecFSH | 38.6 |
| Group | Value (Percentage of participants) |
|---|---|
| 150 µg Corifollitropin Alfa | 39.9 |
| 200 IU RecFSH | 31.8 |
| Group | Value (Percentage of participants) |
|---|---|
| 150 µg Corifollitropin Alfa | 38.7 |
| 200 IU RecFSH | 30.7 |
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| 150 µg Corifollitropin AlfaParticipants from the base study P05787 (NCT00696800), received a single subcutaneous (SC) injection of 150 µg Corifollitropin Alfa on menstrual cycle Day 2/3 (Day 1); 7 daily SC injections from Days 1 to 7 with placebo-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. | – | 1 / 168 | 0 / 168 |
| 200 IU RecFSHParticipants 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. | – | 0 / 176 | 0 / 176 |
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