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Trial · Observational

RecruitingPhase not statedRegistry data

GnRH for Luteal Support - Mechanism of Action

NCTNCT07620067 (opens ClinicalTrials.gov in a new tab)Other idSZMC-0357-22
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Recruiting
Phase
Phase not stated
Enrollment
150 participants (estimated)
Sponsor
Heli Alexandroni · Other
Design
Not stated
Countries
1 country

Israel

Start
18 May 2026
Primary completion
31 Dec 2026 (estimated)
Completion
31 Dec 2026 (estimated)
First posted
2 Jun 2026
Last update posted
2 Jun 2026
Conditions
GnRH Antagonist IVF Protocol · Fresh Embryo Transfer · Administration of Hormonal Luteal Support

Timeline

1 trial · 1 ongoing

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20262027
  1. Ph –

    GnRH for Luteal Support - Mechanism of Action

    NCT07620067

    18 May 2026 to est. 31 Dec 2026

Registry summary

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

This prospective observational study will include women undergoing IVF treatment with a GnRH antagonist protocol and fresh embryo transfer at the IVF unit of Shaare Zedek Medical Center. Patients will undergo controlled ovarian stimulation followed by ovulation triggering with hCG, GnRH agonist, or dual trigger according to OHSS risk. After oocyte retrieval and fertilization by IVF/ICSI, embryos will be cultured and transferred. Luteal phase support will consist of either intranasal GnRH agonist (Synarel) or vaginal progesterone. Blood and follicular fluid samples will be collected at predefined time points to assess hormonal, inflammatory, and angiogenic markers, including LH, FSH, estradiol, progesterone, IL-6, IL-8, VEGF, PEDF, and relaxin.

Interventions

  • GnRH agonistDrug
  • ProgesteroneDrug

Arms2

  • Other

    Luteal support with GnRH agonist

    spray of 200 mcg Nafarelin (Synarel) twice a day for two weeks

  • Other

    Luteal support with vaginal progesterone

    progesterone administered until hCG day and continued for 8-10 weeks if positive

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Positive pregnancy rate

    Time frame · 2 weeks

    Registry description

    serum βhCG ≥ 25 IU/L, measured 14 days after ET.

Secondary outcomes(1)

  1. Level of blood markers along the luteal phase

    Time frame · 2 weeks

    Registry description

    LH, FSH (secreted from pituitary gland), steroid hormones, cytokines, and other proteins secreted from CL (Estradiol, Progesterone, Relaxin, IL-6, IL-8)

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

Studies2

Studies that cite this trial.

Studies with results

1 study 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)

More studies

1 study on this page

PubMed tag: none · 2016

Intranasal gonadotropin-releasing hormone agonist (GnRHa) for luteal-phase support following GnRHa triggering, a novel approach to avoid ovarian hyperstimulation syndrome in high responders.

Bar-Hava et al. 2016Fertility and sterilitycited by 29

PMID 27114332DOI 10.1016/j.fertnstert.2016.04.004PUB-27114332

Full text at the publisher
Publisher page

Eligibility

Who could join, as posted.

Sex
Female
Age
from 18 Years up to 45 Years
Healthy volunteers
Accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * Women included in the study will be 18-45 years old * undergoing IVF treatments due to ovulation disorder, mechanical factor, primary ovarian insufficiency, or male infertility. * All women will be at their first to the third cycle of treatment * women will undergo a fresh ET. Exclusion Criteria: * repeated implantation failure (more than 3 cycles of good quality ET without implantation) * moderate-severe endometriosis * hydrosalpinx * fibroid uterus * BMI more than 35 or less than 19 * women with hypogonadotropic hypogonadism * PGT of embryos * use of surgical techniques for sperm retrieval * preference of the long GnRH-agonist protocol * women with rhinitis or nasal congestion.

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