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Trial · Interventional

Status unknownPhase 4Registry data

Modified Luteal Support for Frozen-Thawed Embryo Transfer - A Prospective Study

NCTNCT02825290 (opens ClinicalTrials.gov in a new tab)Other id2537-15-SMC
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Status unknown
Phase
Phase 4
Enrollment
62 participants (estimated)
Sponsor
Sheba Medical Center · Other gov
Design
Randomized · Double masking
Countries
1 country

Israel

Start
Jul 2016
Primary completion
Jun 2017 (estimated)
Completion
Jun 2017 (estimated)
First posted
7 Jul 2016 (estimated)
Last update posted
13 Dec 2016 (estimated)
Conditions
Embryo Transfer · Luteal Support

Timeline

1 trial

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
201620172018
  1. Ph 4

    Modified Luteal Support for Frozen-Thawed Embryo Transfer - A Prospective Study

    NCT02825290

    Jul 2016 to est. Jun 2017

Registry summary

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

This study evaluates the outcomes of frozen-thawed embryo transfer (FET) success rate with modified luteal support - addition of a single injection of HCG and GnRH-agonist, on day of ET and 4 days later, respectively vs. traditional luteal support with vaginal progesterone only in ovulating women.

Interventions

  • Choriogonadotropin alfaDrug
  • Triptorelin acetateDrug

Arms2

  • Experimental

    Study group

    hCG (Choriogonadotropin alfa; Ovitrelle 250 mcg) on day of embryo transfer \& GnRH-agonist (Triptorelin acetate; Decapeptyl 0.1 mg) after 4 days In addition to the usual progesterone luteal support.

  • No intervention

    Control group

    The usual progesterone only luteal phase support.

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Ongoing pregnancy

    Time frame · About 10-12 weeks after embryo transfer

    Registry description

    Number of viable pregnancies at about 10-12 weeks of gestation.

Secondary outcomes(2)

  1. Implantation rate

    Time frame · 2 weeks after embryo transfer

    Registry description

    Positive BhCG blood test

  2. Clinical pregnancy

    Time frame · About 3-4 weeks after embryo transfer

    Registry description

    Visible intrauterine gestational sacs on ultrasound exam

Posted results

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

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

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

Studies3

Studies that cite this trial.

Studies with results

2 studies on this page

Indexing hint: Randomized controlled trial · 2006

6 results

Beneficial effect of luteal-phase GnRH agonist administration on embryo implantation after ICSI in both GnRH agonist- and antagonist-treated ovarian stimulation cycles.

Tesarik et al. 2006Human reproduction (Oxford, England)cited by 89

PMID 16926261DOI 10.1093/humrep/del173PUB-16926261

Full text at the publisher6 results
Publisher pageSee results (6)

Indexing hint: Clinical trial · 2004

6 results

Enhancement of embryo developmental potential by a single administration of GnRH agonist at the time of implantation.

Tesarik et al. 2004Human reproduction (Oxford, England)cited by 84

PMID 15070873DOI 10.1093/humrep/deh235PUB-15070873

Full text at the publisher6 results
Publisher pageSee results (6)

More studies

1 study on this page

Indexing hint: Observational study · 2015

Modifying the luteal phase support in natural cycle frozen-thawed embryo transfer improves cycle outcome.

Haas et al. 2015Gynecological endocrinology : the official journal of the International Society of Gynecological Endocrinologycited by 10

PMID 26288149DOI 10.3109/09513590.2015.1075502PUB-26288149

Full text at the publisher
Publisher page

Eligibility

Who could join, as posted.

Sex
Female
Age
from 20 Years up to 40 Years
Healthy volunteers
Accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * 20-40 years old women * Spontaneously ovulating women * Treated in our IVF unit for frozen-thawed embryo transfer * At least one top quality embryo Exclusion Criteria: * PGD patients * More than 4 previous embryo transfers

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