Role of Suppression of Endometriosis With Progestins Before IVF-ET

NCT ID: NCT04500743

Last Updated: 2020-08-05

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

134 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-08-01

Study Completion Date

2020-04-30

Brief Summary

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This study aimed to assess the role of Dienogest pretreatment for endometriosis suppression as compared to Gonadotropin-releasing hormone agonist (GnRHa) in patients with endometriosis pursuing IVF treatment.

Detailed Description

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Conditions

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IVF Endometriosis Pregnancy Rate Progestins GnRH-analogue

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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Dienogest

Group Type ACTIVE_COMPARATOR

Dienogest

Intervention Type DRUG

Group B (n=67) who had daily oral Dienogest 2 mg/d for 3 months before starting standard long protocol for IVF

GnRH analogue

Group Type ACTIVE_COMPARATOR

leuprorelin acetate

Intervention Type DRUG

Group A (n=67) who had monthly depot GnRHa for 3 months before ovarian stimulation in IVF treatment (Ultra-long protocol)

Interventions

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Dienogest

Group B (n=67) who had daily oral Dienogest 2 mg/d for 3 months before starting standard long protocol for IVF

Intervention Type DRUG

leuprorelin acetate

Group A (n=67) who had monthly depot GnRHa for 3 months before ovarian stimulation in IVF treatment (Ultra-long protocol)

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* confirmed diagnosis of endometriosis
* body mass index \< 35 Kg/m2

Exclusion Criteria

* if they have been already on long-term down-regulation of the pituitary gland with GnRHa for control of endometriosis
* liver or kidney disease
* evidence of diminished ovarian reserve (e.g. high FSH level \>12 IU/L or low AMH level \<1 ng/ml).
Minimum Eligible Age

30 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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National Research Centre, Egypt

OTHER

Sponsor Role lead

Responsible Party

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Mazen Abdel Rasheed

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Minia Infertility research unit

Minya, , Egypt

Site Status

Countries

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Egypt

References

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Chen I, Kives S, Zakhari A, Nguyen DB, Goldberg HR, Choudhry AJ, Le AL, Kowalczewski E, Schroll JB. Progestagens for pain symptoms associated with endometriosis. Cochrane Database Syst Rev. 2025 Oct 9;10:CD002122. doi: 10.1002/14651858.CD002122.pub3.

Reference Type DERIVED
PMID: 41065045 (View on PubMed)

Khalifa E, Mohammad H, Abdullah A, Abdel-Rasheed M, Khairy M, Hosni M. Role of suppression of endometriosis with progestins before IVF-ET: a non-inferiority randomized controlled trial. BMC Pregnancy Childbirth. 2021 Mar 30;21(1):264. doi: 10.1186/s12884-021-03736-2.

Reference Type DERIVED
PMID: 33784989 (View on PubMed)

Other Identifiers

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Dienogest before IVF

Identifier Type: -

Identifier Source: org_study_id

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