Gonadotropin-releasing Hormone (GnRH) Downregulation Versus Oral Anticonception Prior to ART in Postoperative Endometriosis Patients

NCT ID: NCT02400801

Last Updated: 2024-07-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

166 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-06-30

Study Completion Date

2018-01-26

Brief Summary

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Does prolonged GnRH downregulation prior to ART improve the clinical pregnancy rate in postoperative endometriosis patients? (A single centre randomised controlled trial)

Detailed Description

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Conditions

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Endometriosis Infertility

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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oral oestroprogestogen pre-treatment

preparation with oral oestroprogestogens prior to downregulation in an assisted reproductive technology treatment (ART) cycle

Group Type ACTIVE_COMPARATOR

ethinylestradiol + dienogest

Intervention Type DRUG

oral oestroprogestogen

gonadotropin-releasing hormone (GnRH) pre-treatment

preparation with gonadotropin-releasing hormone (GnRH) analogues prior to downregulation in an assisted reproductive technology treatment (ART) cycle

Group Type EXPERIMENTAL

triptorelin

Intervention Type DRUG

gonadotropin-releasing hormone (GnRH) agonist

Interventions

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triptorelin

gonadotropin-releasing hormone (GnRH) agonist

Intervention Type DRUG

ethinylestradiol + dienogest

oral oestroprogestogen

Intervention Type DRUG

Other Intervention Names

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decapeptyl Louise

Eligibility Criteria

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Inclusion Criteria

* histologically proven endometriosis with complete treatment of all endometriosis lesions during laparoscopy
* only first three ART cycles
* normal uterine cavity
* Eligible for ovarian stimulation with long agonist protocol

Exclusion Criteria

* FSH\>20 IU/L
* presence of large intramural fibroids (\> 3 cm)
* \<4 oocytes obtained in any previous fresh ART cycle
* ART with sperm derived from testicular biopsy
* ART with Preimplantation Genetic Diagnosis/Screening
Minimum Eligible Age

18 Years

Maximum Eligible Age

39 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Universitaire Ziekenhuizen KU Leuven

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Thomas M D'Hooghe, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

UZ Leuven

Locations

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UZ Leuven

Leuven, , Belgium

Site Status

Countries

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Belgium

References

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Tomassetti C, Beukeleirs T, Conforti A, Debrock S, Peeraer K, Meuleman C, D'Hooghe T. The ultra-long study: a randomized controlled trial evaluating long-term GnRH downregulation prior to ART in women with endometriosis. Hum Reprod. 2021 Sep 18;36(10):2676-2686. doi: 10.1093/humrep/deab163.

Reference Type DERIVED
PMID: 34370858 (View on PubMed)

Other Identifiers

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S55300

Identifier Type: -

Identifier Source: org_study_id

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