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NCT00702273·Not applicable·OBSERVATIONAL

Follow-up Study of Frozen-thawed Embryo Transfer (FTET) Cycles After Cryopreservation of Embryos in Clinical Trial P05787 (P05716)

GanirelixOtherCompleted

Status

Completed

Phase

Not applicable

Enrollment

344

Locations

0

Results

Posted

Publications

1

Study summary

What the protocol is testing.

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.

Full 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.

Interventions

Treatment arms and agents.

DRUG

150 µg Corifollitropin Alfa

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.

BIOLOGICAL

200 IU RecFSH/Follitropin beta (Days 1 to 7)

Daily SC injections with 200 IU fixed dose recFSH were started on Stimulation Day 1 and continued up to and including Stimulation Day 7.

DRUG

Placebo for Corifollitropin Alfa

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.

DRUG

Placebo for RecFSH/Follitropin beta

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.

BIOLOGICAL

200 IU RecFSH/Follitropin beta (Days 8 to hCG)

From Stimulation Day 8 onwards a daily SC dose of 200 IU recFSH was administered up to and including the Day of hCG.

DRUG

Ganirelix

On Stimulation Day 5 a daily SC injection of 0.25 mg was started, which continued up to and including the day of hCG

BIOLOGICAL

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

BIOLOGICAL

Progesterone

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.

Timeline

From registration to results.

  1. First posted

    Jun 20, 2008

  2. Study start

    Apr 19, 2006

  3. Primary completion

    May 19, 2009

  4. Study completion

    May 31, 2009

  5. Results posted

    Nov 20, 2014

  6. Registry updated

    Sep 5, 2024

Outcomes

What the study measures.

Primary outcomes

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'.

Secondary outcomes

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.

Eligibility

Who can take part.

Minimum age
18 Years
Maximum age
36 Years
Sex
FEMALE
Healthy volunteers
No

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 locations

0 registered sites.

No country data reported. Showing up to 24 locations stored in the fast local snapshot.

No study locations reported.

Publications

Results and literature.

PMID 22459628 ↗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.

Primary links

Continue at the source.

ClinicalTrials.gov ↗Search PubMed ↗Search FDA ↗Search EMA ↗

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