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

Endometriosis Related Infertility Clinical Trial

Official title:

Surgery Before Embryo Transfer in Endometrioma Related Reduction in Ovarian Reserve

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04233983
• Other study ID #: 2019-19/12
• Status: Not yet recruiting
• Phase: N/A
• Start date: February 1, 2020
• Est. completion date: March 1, 2021

Study information

• Verified date: January 2020
• Source: Uludag University
• Contact: Kiper Aslan, M.D
• Phone: +902242952541
• Email: kiperaslan[@]yahoo.com.tr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: March 1, 2021
• Est. primary completion date: January 1, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 23 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Endometriosis
• Endometriosis Related Infertility
• Infertility

Intervention

Procedure:
• 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.

Locations

Country	Name	City	State
Turkey	Uludag University ART Center	Bursa

Sponsors (1)

Lead Sponsor	Collaborator
Uludag University

Country where clinical trial is conducted

Turkey, 

References & Publications (2)

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 2 — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Positive b-hCG Rate	Postoperative 6. months positive b-hCG rates will be compared with control group.	6 months