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Trial · Interventional

CompletedPhase 4Registry data

Addition of Gonadotropin Releasing Hormone Agonist to Luteal Phase Support

NCTNCT05286554 (opens ClinicalTrials.gov in a new tab)Other id0201599
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 4
Enrollment
75 participants (actual)
Sponsor
Alexandria University · Other
Design
Randomized · Open label (no masking)
Countries
1 country

Egypt

Start
17 Mar 2022
Primary completion
27 Oct 2023
Completion
18 Jan 2024
First posted
18 Mar 2022
Last update posted
29 Jan 2025
Conditions
Female Infertility

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2022202320242025
  1. Ph 4

    Addition of Gonadotropin Releasing Hormone Agonist to Luteal Phase Support

    NCT05286554

    17 Mar 2022 to 18 Jan 2024

Registry summary

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

Hormonal milieu during implantation is crucial to embryo-endometrium interaction and to the viability of the conceptus. Alterations in the peri-implantation environment are considered to impair perinatal outcomes in intracytoplasmic sperm injection (ICSI) therapy. GnRH-a is a new and promising modality for LPS. Regimens for using GnRH-a in LPS, including single mid-luteal bolus or the addition of a GnRH-a to progesterone supplementation, have been recently suggested. The aim of this study is to evaluate the impact of addition of mid-luteal single-dose or multiple-dose GnRH agonist to the routine luteal phase support in patients undergoing ICSI cycles using GnRH antagonist protocol.

Interventions

  • gonadotropin releasing hormone-agonistDrug
  • ProgesteroneDrug

Arms3

  • Experimental

    Group 1

    Will receive routine LPS and additional single GnRH-a bolus, triptorelin 0.1 mg subcutaneous injection on the 6th day after oocyte retrieval.

  • Experimental

    Group 2

    Will receive routine LPS and additional multiple mid-luteal GnRH-a, triptorelin 0.1 mg subcutaneous injection on the 5th, 7th and 9th days after oocyte retrieval.

  • Active comparator

    Group 3 (Control)

    Will receive the routine LPS without GnRH-a

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Clinical pregnancy rate

    Time frame · 2 weeks after positive pregnancy test

    Registry description

    Calculated as the number of clinical pregnancies (Presence of an intrauterine gestational sac with embryonic cardiac activity observed by vaginal ultrasound) divided by the number of embryo transfer procedures.

Secondary outcomes(3)

  1. Implantation rate

    Time frame · 2 weeks after positive pregnancy test

    Registry description

    the ratio of the number of gestational sacs detected by sonography to the total number of embryos transferred.

  2. Multiple pregnancy rate

    Time frame · 8 weeks of gestation

    Registry description

    The percentage of pregnancies with more than one fetus

  3. Serum β-human chorionic gonadotropin (β-HCG) concentration

    Time frame · 15 days after ICSI

    Registry description

    In milli-International unit/ml on day 15 after ICSI

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.

Completed trials do not always post results.

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

Studies2

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)

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: 1. Patient age ≤ 38 years. 2. BMI ≤ 30. 3. Basal follicle stimulating hormone (FSH) level ≤ 10 IU/L. 4. Anti-Müllerian hormone (AMH): ≤ 5 ng/ml. Exclusion Criteria: 1. Endometriosis. 2. Polycystic ovarian syndrome (PCOS). 3. Uterine pathology or anomaly. 4. Evidence of hydrosalpinx by hysterosalpingography or ultrasound. 5. Comorbidities: Diabetes mellitus, hypertension, immune diseases.

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