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

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

Detailed Description
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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.

Official Title
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Surgery Before Embryo Transfer in Endometrioma Related Reduction in Ovarian Reserve

Conditions
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Endometriosis Related Infertility

Intervention / Treatment
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* Procedure: Laparoscopic Endometriosis Surgery


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 23 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Prospective Randomised Controlled Trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Study Group<br>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. | Procedure: Laparoscopic Endometriosis Surgery<br>* 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.<br>|
| No Intervention: Control Group<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Positive b-hCG Rate | Postoperative 6. months positive b-hCG rates will be compared with control group. | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Endometriosis, Laparoscopy, Infertility, Ovarian Reserve, Endometrioma