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UnknownNCT04233983

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
Phase
N/A
Study type
Interventional
Enrollment
40 (estimated)
Sponsor
Uludag University · Academic / Other
Sex
Female
Age
23 Years – 40 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
PROCEDURELaparoscopic Endometriosis SurgeryPatient 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.

Timeline

Start date
2020-02-01
Primary completion
2021-01-01
Completion
2021-03-01
First posted
2020-01-18
Last updated
2020-01-18

Locations

1 site across 1 country: Turkey (Türkiye)

Source: ClinicalTrials.gov record NCT04233983. Inclusion in this directory is not an endorsement.