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Trial · Interventional

Status unknownPhase 4Registry data

GnRHa for Luteal Phase Support in GnRH Antagonist Protocol Cycles

Overview

Status
Status unknown
Phase
Phase 4
Enrollment
200 participants (estimated)
Sponsor
Mansoura University · Other
Design
Randomized · Open label (no masking)
Countries
1 country

Egypt

Start
7 Aug 2016
Primary completion
31 Dec 2024 (estimated)
Completion
31 Dec 2024 (estimated)
First posted
9 Dec 2014 (estimated)
Last update posted
30 Oct 2023
Conditions
Infertility

Timeline

1 trial

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20162018202020222024
  1. Ph 4

    GnRHa for Luteal Phase Support in GnRH Antagonist Protocol Cycles

    NCT02312089

    7 Aug 2016 to est. 31 Dec 2024

Registry summary

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

Evaluation of the effect of adding a single dose of gonadotropin releasing hormone agonist (GnRHa) as a luteal phase support on the outcomes of intracytoplasmic sperm injection (ICSI) following GnRH antagonist protocol

Interventions

  • TriptorelinDrug

Arms2

  • Active comparator

    GnRHa group

    Luteal phase SC administration of a single dose (0.2 mg) of GnRHa (Triptorelin)

  • No intervention

    Control group

    No GnRHa administration in luteal phase

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Clinical pregnancy rate

    Time frame · 6 weeks after embryo transfer

    Registry description

    Number of clinical pregnancies (defined as presence of at least one intrauterine gestational sac with fetal pole and cardiac activity on TVS scan at 4-6 weeks after the ET) divided by the number of ET procedures

Secondary outcomes(2)
  1. Implantation rate

    Time frame · 6 weeks after embryo transfer

    Registry description

    Number of gestational sacs on TVS scan at 4-6 weeks after ET divided by the number of transferred embryos

  2. Miscarriage rate

    Time frame · 12 weeks gestational age

    Registry description

    Number of first trimester miscarriages (before 12 weeks gestational age) divided by the number of clinical pregnancies

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

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
Female
Age
from 20 Years up to 38 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * Women subjected to ICSI through controlled ovarian hyperstimulation (COH) with pituitary downregulation by GnRH antagonist. Exclusion Criteria: * Moderate or severe endometriosis. * Hydrosalpinx. * Uterine abnormalities. * Myoma. * Previous uterine surgery.

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