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Completed

NCT Number: NCT00702546

Follow-up Protocol on the Outcome of Frozen-thawed Embryo Transfer Cycles From Clinical Trial P05690 (P05711)

Clinical trial objective is to collect the outcome of Frozen-Thawed Embryo Transfer (FTET) cycles performed after the embryos are cryopreserved in the base study P05690 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 FTET cycles, performed after the embryos are cryopreserved in base study P05690 (NCT00702845), 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 study P05690, of which at least one embryo is thawed for use in a subsequent FTET cycle;
  • Able and willing to give written informed consent.

Exclusion criteria

  • None

Treatment and study plan

Corifollitropin alfa

Drug

Single injection of 100 μg corifollitropin alfa administered under protocol P05690

Other names: Org 36286

recFSH (follitropin alfa)

Biological

Daily recFSH administered under protocol P05690

Other names: Puregon®/Follistim®

gonadatropin releasing hormone (GnRH) antagonist ganirelix

Drug

GnRH antagonist ganirelix administered SC at a dose of 0.25 mg/day under protocol P05690

human chorion gonadatropin (hCG)

Drug

hCG 5,000 IU or 10,000 IU administered SC under protocol P05690

progesterone

Biological

Under protocol P05690, progesterone was started on the day of oocyte pick-up (OPU) and continued for at least 6 weeks or up to menses. Participants received at least 600 mg/day vaginally or 50 mg/day IM.

placebo-recFSH (follitropin alfa)

Drug

Placebo-recFSH at the equivalent volume of 150 IU/day administered under protocol P05690

placebo-corifollitropin alfa

Drug

Single SC injection of placebo-corifollitropin alfa on Day 2 or 3 of the menstrual cycle, administered under protocol P05690

open-label recFSH

Biological

Open-label recFSH up to a maximum dose of 200 IU/day, administered under protocol P0590

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 P05690 (NCT00702845), and FTET cycles in follow up study P05711

    Cumulative ongoing pregnancy rate was defined as 100 times the number of participants with an ongoing pregnancy either immediately after embryo transfer in base study P05690 (NCT00702845) or after one or more FTET cycles in follow up study P05711 following cryopreservation, divided by the total number of subjects that started treatment in base study P05690.

Secondary outcomes

  1. Percentage of Participants in Follow up Study With a Miscarriage Per Clinical Pregnancy

    Time frame: After one or more FTET cycles, assessed at least 10 weeks after embryo transfer (up to 1 year)

    Miscarriages were calculated per clinical pregnancy, defined as the presence of at least one gestational sac as assessed by USS or Doppler, or confirmed by live birth.

  2. Percentage of Participants in Follow up Study With a Miscarriage Per Vital Pregnancy

    Time frame: After one or more FTET cycles, assessed at least 10 weeks after embryo transfer (up to 1 year)

    Miscarriages were calculated per vital pregnancy, defined as the presence of at least one fetus with heart activity as assessed by USS or Doppler, or confirmed by live birth.

  3. Percentage of Participants in Follow up Study With an Ecotopic 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 Study 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 Study 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 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 107012

Important dates

Study start
2006
Primary completion
2008
Study completion
2008
First posted
Jun 20, 2008
Registry last updated
Feb 3, 2022

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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