NCT03620838

Brief Summary

The present multi-center study aimed to evaluate whether endometrioma-associated decline in ovarian reserve is progressive in the absence of an intervention and is greater in magnitude than the natural decline over time. Also the affect of endometrioma treatment modalities like surgery or medical on the ovarian reserve over time.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
250

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2019

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 23, 2018

Completed
16 days until next milestone

First Posted

Study publicly available on registry

August 8, 2018

Completed
7 months until next milestone

Study Start

First participant enrolled

March 1, 2019

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2020

Completed
Last Updated

October 10, 2019

Status Verified

October 1, 2019

Enrollment Period

1.5 years

First QC Date

July 23, 2018

Last Update Submit

October 8, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • AMH

    Change from baseline Anti müllerian hormone levels at 6 months

    6 months

Secondary Outcomes (1)

  • AFC

    6 months

Study Arms (5)

Group 1

Patients with endometrioma who had at least one endometrioma \>3 cm and who will not need hormonal or surgical treatment at the time of diagnosis and who will be expectantly managed

Group 2

Patients with endometrioma who had at least one endometrioma \>3 cm and who will be treated with OCP during the study period

Drug: oral contraceptive pill, oral progesterone

Group 3

Patients with endometrioma who had at least one endometrioma \>3 cm and who will be treated with oral progesterone during the study period

Drug: oral contraceptive pill, oral progesterone

Group 4

Patients with endometrioma who had at least one endometrioma \>3 cm and who will be treated with surgery short after recruitment

Drug: oral contraceptive pill, oral progesterone

Group 5

The control group, who do not have endometrioma and any gynecological disorder

Interventions

ovarian endometrioma cyst excision

Also known as: surgery
Group 2Group 3Group 4

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Patients with endometriomas

You may qualify if:

  • Women between 18 and 40 years of age
  • Who had at least one endometrioma \>3 cm

You may not qualify if:

  • İrregular periods
  • Polycystic ovarian syndrome
  • Pregnant patients
  • Patients unable to give informed consent • Using medication which could affect ovarian function during six months before recruitment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Uludag University Scholl of medicine

Bursa, Turkey/bursa, Turkey (Türkiye)

RECRUITING

Related Publications (1)

  • Aslan K, Kasapoglu I, Kosan B, Gurbuz TB, Muzii L, Uncu G. Impact of endometrioma management strategies on ovarian reserve over the follow-up period, a prospective longitudinal study. Front Endocrinol (Lausanne). 2025 Sep 11;16:1631108. doi: 10.3389/fendo.2025.1631108. eCollection 2025.

MeSH Terms

Conditions

Endometriosis

Interventions

Contraceptives, OralProgesteroneSurgical Procedures, Operative

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Contraceptive Agents, FemaleContraceptive AgentsReproductive Control AgentsPhysiological Effects of DrugsPharmacologic ActionsChemical Actions and UsesTherapeutic UsesPregnenedionesPregnenesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsCorpus Luteum HormonesGonadal HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsProgesterone CongenersGonadal Steroid Hormones

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator ; Prof. Dr. Gürkan Uncu

Study Record Dates

First Submitted

July 23, 2018

First Posted

August 8, 2018

Study Start

March 1, 2019

Primary Completion

September 1, 2020

Study Completion

September 1, 2020

Last Updated

October 10, 2019

Record last verified: 2019-10

Locations