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Surgery Before Embryo Transfer in ERROR (Endometrioma Related Reduction in Ovarian Reserve)

Surgery Before Embryo Transfer in Endometrioma Related Reduction in Ovarian Reserve

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04233983
Enrollment
40
Registered
2020-01-18
Start date
2020-02-01
Completion date
2021-03-01
Last updated
2020-01-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Endometriosis Related Infertility

Keywords

Endometriosis, Laparoscopy, Infertility, Ovarian Reserve, Endometrioma

Brief summary

This prospective study evaluates the pregnancy results after laparoscopic endometriosis operation in infertile patients with ERROR (endometrioma related reduction in ovarian reserve)

Detailed description

This study consists of two groups. Patients will be randomly enrolled into the groups by ART (assisted reproductive technology) centre nursery. All patients will sign a consent form about procedure. Patients diagnosed with endometrioma (larger than 3 cm diameter) and ERROR (endometrioma related reduction in ovarian reserve - Antimullerian Hormon \< 1.2 ng/ml, Antral follicle count \< 7 , Day3 Follicle Stimulating Hormone \> 10 IU/dl, Low response to ovarian hyper stimulation \< 3 oocytes) will be enrolled in study. Patients with age \>40, with male factor, with undefined adnexal mass, malignity suspicion will be excluded from study. The study group consists of patients who will undergo laparoscopic endometriosis surgery after ICSI procedure with freezing all embryos. The patients will wait about 6 months for spontaneous conception, if there is no pregnancy during this period, frozen embryo transfer will be performed. The control group consists of patients who will be performed IVF&ICSI procedure with fresh embryo transfer without surgery. If there is no pregnancy, patients will be operated then. As the primary; result positive b-hCG rates will be compared between groups. In conclusion we will find out whether laparoscopic endometriosis operation improves or worsens the pregnancy results in patients with ERROR.

Interventions

Patient with ERROR(endometrioma related reduction in ovarian reserve), and endometrioma larger than 3 cm diameter will be operated after IVF&ICSI procedure. Operation will be done by senior surgeons of our department. Laparoscopic endometrioma operation procedure consists of excision of endometrioma cyst with its capsule from ovary without using any electric modality to prevent ovarian damage.

Sponsors

Uludag University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

Prospective Randomised Controlled Trial

Eligibility

Sex/Gender
FEMALE
Age
23 Years to 40 Years
Healthy volunteers
No

Inclusion criteria

* Presence of Endometrioma at least in one ovary, larger than 3 cm diameter * Endometriosis Related Reduction in Ovarian Reserve (ERROR) * Presence of endometriosis related infertility

Exclusion criteria

* Presence of chronic systemic disease * Presence of male factor infertility * Suspicion of ovarian malignancy or undefined ovarian mass

Design outcomes

Primary

MeasureTime frameDescription
Positive b-hCG Rate6 monthsPostoperative 6. months positive b-hCG rates will be compared with control group.

Countries

Turkey (Türkiye)

Contacts

Primary ContactKiper Aslan, M.D
kiperaslan@yahoo.com.tr+902242952541
Backup ContactIsil Kasapoglu, Asc. Prof.
kasapogluisil@hotmail.com+902242952541

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026