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Completed

NCT Number: NCT00702273

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

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.

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Key information

Conditions

In Vitro Fertilization

Age range

18 year–36 year

Sex eligibility

Female

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

150 µg Corifollitropin Alfa

Drug

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.

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

Biological

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

Placebo for Corifollitropin Alfa

Drug

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.

Placebo for RecFSH/Follitropin beta

Drug

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.

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

Biological

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

Ganirelix

Drug

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

hCG

Biological

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

progesterone

Biological

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.

Primary outcomes

  1. 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

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

Sponsors and collaborators

Lead sponsor

Organon and Co

Industry

Registry information

Official study title

Follow-up Protocol to Collect the Outcome of Frozen-thawed Embryo Transfer Cycles After Cryopreservation of Embryos in Clinical Trial 38819

Important dates

Study start
2006
Primary completion
2009
Study completion
2009
First posted
Jun 20, 2008
Registry last updated
Sep 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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