NCT04356664

Brief Summary

Women suffering from endometriosis and/or adenomyosis may also suffer from infertility. GnRH agonist injection could improve implantation and therefore increase the pregnancy rate in these patients. This study was designed to evaluate effects of the additional of GnRH agonist (single or 2 doses) to the routine oestrogens and progestins use as support before Frozen Embryon Transfer as compared to oestrogens and progestins only.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
180

participants targeted

Target at P75+ for phase_2

Timeline
1mo left

Started Mar 2021

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress98%
Mar 2021Jun 2026

First Submitted

Initial submission to the registry

April 20, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 22, 2020

Completed
11 months until next milestone

Study Start

First participant enrolled

March 18, 2021

Completed
5.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 18, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 18, 2026

Last Updated

January 16, 2026

Status Verified

January 1, 2026

Enrollment Period

5.3 years

First QC Date

April 20, 2020

Last Update Submit

January 15, 2026

Conditions

EndometriosisAdenomyosisInfertility, Female

Outcome Measures

Primary Outcomes (1)

  • Clinical pregnancy rate in both groups at last visit ultrasound

    Clinical pregnancy will be defined by any cardiac activity detected during the ultrasound performed at the last visit.

    3 months after frozen embryon transfer

Secondary Outcomes (3)

  • Successful implantation rate on the number of patients included

    3 months after frozen embryon transfer

  • Rates of miscarriages on the number of patients included

    3 months after frozen embryon transfer

  • Side effects related to treatment with Decapeptyl 3 mg

    15 months

Study Arms (2)

Frozen embryo transfer with Hormonal Replacement Therapy (HRT)

NO INTERVENTION

Patient will received usual Hormonal Replacement Therapy for a Frozen embryo transfer composed of estrogens and progestins.

Frozen embryo transfer with HRT and GnRH agonist

EXPERIMENTAL

Patient will received 1 or 2 injection of GnRH agonist priori to usual Hormonal Replacement Therapy for a Frozen embryo transfer composed of estrogens and progestins.

Drug: GnRH agonist

Interventions

GnRH agonistDRUG

One or two intramuscular injections of Decapeptyl 3 mg

Also known as: Decapeptyl 3 mg
Frozen embryo transfer with HRT and GnRH agonist

Eligibility Criteria

Age18 Years - 36 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsTreatment of female infertility
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Women aged 18 to 36 years (women ≥18 years to \<36 years) with endometriosis and / or adenomyosis
  • Having benefited from In vitro fertilisation /intracytoplasmic micro-injection with freeze all and for whom the frozen embryon transfer of a blastocyst is planned
  • A normal uterine cavity
  • Having signed a consent form
  • Being affiliated to a Health Insurance Plan.

You may not qualify if:

  • Patient aged \<18 years and ≥ 36 years
  • BMI\> 35
  • History of implantation failures (≥ 2)
  • Endometrial alterations: synechiae, polyps, myomas, hyperplasia, hematometra
  • known hydrosalpinx uni or bilateral
  • MRI showing no endometriosis or adenomyosis
  • Hypersensitivity to GnRH, GnRH analogues, or any of the excipients of Decapeptyl 3 mg
  • Known hypersensitivity to estradiol
  • Known hypersensitivity to progesterone
  • Known hypersensitivity to acetylsalicylic acid or other nonsteroidal anti-inflammatory drugs
  • Known hypersensitivity to folic acid
  • Known hypersensitivity to cefixime or an antibiotic in the cephalosporin group
  • Known hypersensitivity to levofloxacin or any other quinolone
  • History of tendinopathies related to the administration of fluoroquinolones
  • Epilepsy
  • +16 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hopital Foch

Suresnes, 92150, France

RECRUITING

MeSH Terms

Conditions

EndometriosisAdenomyosisInfertility, Female

Interventions

Gonadotropin-Releasing HormoneTriptorelin Pamoate

Condition Hierarchy (Ancestors)

Genital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesUterine DiseasesInfertility

Intervention Hierarchy (Ancestors)

Pituitary Hormone-Releasing HormonesHypothalamic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsNeuropeptidesPeptidesAmino Acids, Peptides, and ProteinsOligopeptidesNerve Tissue ProteinsProteins

Study Officials

  • Paul Pirtea, Dr

    Hopital Foch

    STUDY DIRECTOR

Central Study Contacts

Elisabeth Hulier-Ammar, Dr

CONTACT

0033146251175e.hulier-ammar@hopital-foch.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 20, 2020

First Posted

April 22, 2020

Study Start

March 18, 2021

Primary Completion (Estimated)

June 18, 2026

Study Completion (Estimated)

June 18, 2026

Last Updated

January 16, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)