Surgery Before Embryo Transfer in ERROR (Endometrioma Related Reduction in Ovarian Reserve)
NCT ID: NCT04233983
Last Updated: 2020-01-18
Study Results
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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UNKNOWN
NA
40 participants
INTERVENTIONAL
2020-02-01
2021-03-01
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Study Group
The study group consists of ERROR(endometrioma related reduction in ovarian reserve) 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.
Laparoscopic Endometriosis Surgery
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.
Control Group
The control group consists of ERROR(endometrioma related reduction in ovarian reserve) patients who will be performed IVF\&ICSI procedure with fresh embryo transfer without surgery. If there is no pregnancy, patients will be operated then.
No interventions assigned to this group
Interventions
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Laparoscopic Endometriosis Surgery
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.
Eligibility Criteria
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Inclusion Criteria
* Endometriosis Related Reduction in Ovarian Reserve (ERROR)
* Presence of endometriosis related infertility
Exclusion Criteria
* Presence of male factor infertility
* Suspicion of ovarian malignancy or undefined ovarian mass
23 Years
40 Years
FEMALE
No
Sponsors
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Uludag University
OTHER
Responsible Party
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GÜRKAN UNCU,PROF. MD
Prof. Dr.
Principal Investigators
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Gurkan Uncu, Prof.
Role: STUDY_DIRECTOR
Bursa Uludag University School of Medicine ART Center
Locations
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Uludag University ART Center
Bursa, , Turkey (Türkiye)
Countries
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Central Contacts
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References
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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.
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.
Other Identifiers
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2019-19/12
Identifier Type: -
Identifier Source: org_study_id
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