Clinical trial NCT04233983: Surgery Before Embryo Transfer in ERROR (Endometrioma Related Reduction in Ovarian Reserve)
Official title: Surgery Before Embryo Transfer in Endometrioma Related Reduction in Ovarian Reserve
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Endometriosis Related Infertility
Keywords: Endometriosis
Laparoscopy
Infertility
Ovarian Reserve
Endometrioma
Lead sponsor: Uludag University
Sponsor class: OTHER
First posted: 2020-01-18
Enrollment: 40
Sex: FEMALE
Minimum age (years): 23
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective Randomised Controlled Trial
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Positive b-hCG Rate
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Bursa
country: Turkey
facility: Uludag University ART Center
Study officials:
affiliation: Bursa Uludag University School of Medicine ART Center
name: Gurkan Uncu, Prof.
role: STUDY_DIRECTOR
References:
citation: Muzii L, Di Tucci C, Di Feliciantonio M, Marchetti C, Perniola G, Panici PB. The effect of surgery for endometrioma on ovarian reserve evaluated by antral follicle count: a systematic review and meta-analysis. Hum Reprod. 2014 Oct 10;29(10):2190-8. doi: 10.1093/humrep/deu199. Epub 2014 Aug 1.
citation: Kasapoglu I, Ata B, Uyaniklar O, Seyhan A, Orhan A, Yildiz Oguz S, Uncu G. Endometrioma-related reduction in ovarian reserve (ERROR): a prospective longitudinal study. Fertil Steril. 2018 Jul 1;110(1):122-127. doi: 10.1016/j.fertnstert.2018.03.015. Epub 2018 Jun 20.