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

Bursa Uludag University

Status: Unknown

Conditions: Endometriosis Related Infertility

Treatments: Procedure: Laparoscopic Endometriosis Surgery

Study type: Interventional

Funder types: Other

Identifiers

NCT04233983

2019-19/12

Details and patient eligibility

About

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

Full 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.

Enrollment: 40 estimated patients

Sex: Female

Ages: 23 to 40 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Study Group

Active Comparator group

Description:

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.

Treatment:

Procedure: Laparoscopic Endometriosis Surgery

Control Group

No Intervention group

Description:

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.