NCT06577974

Brief Summary

The aim of this study to assess the effect of medical treatment prior to stimulation on fertility (ICSI) outcome in cases with endometriosis associated infertility.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
129

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

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 Start

First participant enrolled

July 1, 2024

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 16, 2024

Completed
13 days until next milestone

First Posted

Study publicly available on registry

August 29, 2024

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2025

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2025

Completed
Last Updated

August 29, 2024

Status Verified

August 1, 2024

Enrollment Period

8 months

First QC Date

August 16, 2024

Last Update Submit

August 27, 2024

Conditions

Endometriosis

Keywords

Oocyte yield, fertilisation rate

Outcome Measures

Primary Outcomes (1)

  • Fertilisation rate

    Number of embryos

    2 weeks from starting induction

Secondary Outcomes (1)

  • clinical pregnancy rate

    2 weeks from embryo transfer

Study Arms (3)

Those treated by COCPs before IVSI

EXPERIMENTAL

Those with endometrisosis who will undergo ICSI after pretreatment with COCPs

Drug: Combined contraceptive pills (Yasmin)

Those treated by Dionogest before ICSI

EXPERIMENTAL

Patients diagnosed with endometriosis who will undergo ICSI after oreteatment by dienogest

Drug: Combined contraceptive pills (Yasmin)

Those undergoing ICSI straighaway

NO INTERVENTION

patients diagnosed with endometriosis who will undergo ICSI without any medical pretretament

Interventions

Combined contraceptive pills (Yasmin)DRUG

medical pretreatment prior to ICSI

Also known as: Dienogest (Visanne)
Those treated by COCPs before IVSIThose treated by Dionogest before ICSI

Eligibility Criteria

Age20 Years - 40 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Presence of Endometrioma on ultrasound.
  • History of ovarian cystectomy either open or via laparoscopic surgery.
  • Presence of endometriotic foci in the pelvis during laparoscopic surgery.
  • Patients coming for the first ICSI / IVF cycle.

You may not qualify if:

  • Age above 40 years
  • Cases with endometrioma on ultrasound more than 3 cm size.
  • Prior failed ICSI / IVF.
  • Known poor responders or poor ovarian reserve, defined as AFC\<5 or AMH \< 0.5 .
  • Patients with previous uterine surgery.
  • Patients diagnosed to have uterine abnormalities

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

ART unit, Obstetrics and Gynecology Department, Cairo University

Cairo, Egypt

RECRUITING

Cairo University/Obstetrics and Gynecology Department/ART Unit

Cairo, Egypt

RECRUITING

MeSH Terms

Conditions

Endometriosis

Interventions

drospirenone and ethinyl estradiol combinationdienogest

Condition Hierarchy (Ancestors)

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

Study Officials

  • Ahmed Taha, Professor

    Cairo University

    STUDY CHAIR

Central Study Contacts

Mariam Dawoud, A. Professor

CONTACT

01157355666zdawoud9@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

August 16, 2024

First Posted

August 29, 2024

Study Start

July 1, 2024

Primary Completion

February 28, 2025

Study Completion

March 1, 2025

Last Updated

August 29, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share

Study protocol, excel sheet

Locations

EG(2)