Skip to content

Trial · Observational

CompletedPhase not statedResults postedRegistry data

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

NCTNCT00702546 (opens ClinicalTrials.gov in a new tab)Other idP05711Other id2006-003813-42Other id107015Other idMK-8962-004
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase not stated
Enrollment
102 participants (actual)
Sponsor
Organon and Co · Industry
Design
Not stated
Countries
Not stated
Start
Dec 2006
Primary completion
Dec 2008
Completion
Dec 2008
First posted
20 Jun 2008 (estimated)
Last update posted
3 Feb 2022
Conditions
In Vitro Fertilization

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2006200720082009
  1. Ph –

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

    NCT00702546

    Dec 2006 to Dec 2008

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • corifollitropin alfaDrug
  • recFSH (follitropin alfa)Biological
  • gonadatropin releasing hormone (GnRH) antagonist ganirelixDrug
  • human chorion gonadatropin (hCG)Drug
  • progesteroneBiological
  • placebo-recFSH (follitropin alfa)Drug
  • placebo-corifollitropin alfaDrug
  • open-label recFSHBiological

Arms2

  • Other

    Corifollitropin alfa 100 μg

    In follow-up study, no medication or investigational product was administered. But in base study P05690 (NCT00702845), participants received single subcutaneous (SC) injection of corifollitropin alfa 100 μg (Org 36286) on Day 2 or 3 of the menstrual cycle and daily placebo-recombinant Follicle Stimulating Hormone (recFSH) injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants in base study P05690 also received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including Day of Human Chorion Gonadotropin (hCG) administration. Participants also received Gonadotropin Releasing Hormone (GnRH) antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including the Day of hCG (10,000 or 5,000 IU/USP). Participants also received progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on day of oocyte pick-up (OPU) and continuing for at least 6 weeks or up to menses.

  • Other

    recFSH 150 IU

    In this follow-up study, no medication or investigational product was administered. However, in base study P05690 (NCT00702845), participants in the reference group received a single SC injection of placebo-corifollitropin alfa administered on Day 2 or 3 of the menstrual cycle and daily SC recFSH 150 IU injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants also received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including the day of hCG (10,000 or 5,000 IU/USP) administration. Participants also received the GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including the Day of hCG. Participants also received progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on the day of OPU and continuing for at least 6 weeks or up to menses.

Primary outcomes1

Outcomes the sponsor listed as primary.

  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

    Registry description

    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(6)

  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)

    Registry description

    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)

    Registry description

    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)

    Registry description

    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)

    Registry description

    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)

    Registry description

    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)

    Registry description

    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.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeNumber· Up to 1 year after embryo transfer in base trial P05690 (NCT00702845), and FTET cycles in follow up study P05711

Percentage of Participants With an Ongoing Pregnancy (Cumulative Ongoing Pregnancy Rate)

GroupValue (Percentage of participants)
Corifollitropin Alfa 100 μg32.1
recFSH 150 IU41.4
Secondary and other outcome results(6)
Secondary outcomeNumber· After one or more FTET cycles, assessed at least 10 weeks after embryo transfer (up to 1 year)

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

GroupValue (Percentage of participants)
Corifollitropin Alfa 100 μg13.6
recFSH 150 IU10.0
Secondary outcomeNumber· After one or more FTET cycles, assessed at least 10 weeks after embryo transfer (up to 1 year)

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

GroupValue (Percentage of participants)
Corifollitropin Alfa 100 μg0.0
recFSH 150 IU0.0
Secondary outcomeNumber· After one or more FTET cycles, assessed at least 10 weeks after embryo transfer (up to 1 year)

Percentage of Participants in Follow up Study With an Ecotopic Pregnancy

GroupValue (Percentage of participants)
Corifollitropin Alfa 100 μg1.3
recFSH 150 IU0.0
Secondary outcomeNumber· After one or more FTET cycles, assessed at least 10 weeks after embryo transfer (up to 1 year)

Percentage of Participants in Follow up Study With a Clinical Pregnancy

GroupValue (Percentage of participants)
Corifollitropin Alfa 100 μg28.6
recFSH 150 IU40.0
Secondary outcomeNumber· After one or more FTET cycles, assessed at least 10 weeks after embryo transfer (up to 1 year)

Percentage of Participants in Follow up Study With a Vital Pregnancy

GroupValue (Percentage of participants)
Corifollitropin Alfa 100 μg24.7
recFSH 150 IU36.0
Secondary outcomeNumber· After one or more FTET, assessed at least 10 weeks after embryo transfer or at live birth (up to 1 year)

Percentage of Participants With an Ongoing Pregnancy

GroupValue (Percentage of participants)
Corifollitropin Alfa 100 μg23.4
recFSH 150 IU36.0

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
Corifollitropin Alfa 100 μgParticipants in base study P05690 received single SC injection of corifollitropin alfa 100 μg (Org 36286) on Day 2 or 3 of menstrual cycle and daily placebo-recFSH injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including Day of hCG administration. Participants also received GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including Day of hCG (10,000 or 5,000 IU/USP); and progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on Day of OPU and continuing at least 6 weeks or up to menses. Eligible participants from base study were enrolled in follow up study P05711, but no study treatments were given, and embryos obtained in base study underwent FTET cycles.–1 / 770 / 0
recFSH 150 IUParticipants in the reference group in base study P05690 received a single SC injection of placebo-corifollitropin alfa administered on Day 2 or 3 of the menstrual cycle and daily SC recFSH 150 IU injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants also received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including the Day of hCG administration. Participants also received the GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including the Day of hCG (10,000 or 5,000 IU/USP). Participants also received progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on the Day of OPU and continuing for at least 6 weeks or up to menses. Eligible participants from the base study were enrolled in follow up study P05711, but no study treatments were given, and embryos obtained in the base study underwent FTET cycles.–0 / 250 / 0

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
Female
Age
from 18 Years up to 36 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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

PepBank is a research reference. Talk to a doctor before you use any peptide.