Clinical trial NCT03476759: Laparoscopic Tubal Adhesiolysis Versus IVF-ICSI
Official title: Laparoscopic Tubal Adhesiolysis Versus IVF-ICSI in Cases of Post Caesarean Section Adhesions, Which is the Best?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tubal Factor Infertility
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2018-03-26
Enrollment: 300
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 2groups with peritoneal adhesions after cesarean delivery will be allocated to either laparoscopic tubal adhesiolysis or to IVF/ICSI

Detailed description: This randomized clinical trial will be conducted at Tanta university hospitals in fertility and MIS units. Two hundred and fifty 2ry infertility patients with confirmed post C.S adhesions will be included in the study and those patients will be divided randomly in two groups:

Group A:

125 patients will be undergoing laparoscopic tubal adhesiolysis and\\or tuboplasty then a widow of 12 months post operatively is given for natural conception.

Group B:

125 patients will undergo IVF-ICSI procedures. The primary outcome measure of the study will be the rate of clinical pregnancy.

Inclusion criteria:

* patient's age not exceeding 35 years old
* confirmed post caesarean section tubal adhesions (by diagnostic laparoscopy report or video CDs) as a solitary cause of their 2ry infertility.

Exclusion criteria:

* patient's age \>35 years
* other causes of infertility as male factor contribution, any ovulatory or endocrinological disorder,
* diagnosed any degree of endometriosis
* patients with history of recurrent pregnancy loss.
* couples with prolonged sexual abstinence for any reason Detailed explanation of the aims, procedures, steps and nature of the study for the participants will be done and a written consent will be signed by each patient before inclusion.

After allocation laparoscopic tubal adhesions will be dissected and normal anatomy and function will be restored. In the other group IVF/ICSI will be commenced The follow up with both groups will extend to 1year or till pregnancy is aggrieved The outcomes of the study were pregnancy rates and affordability

Eligibility criteria: Inclusion Criteria:

* age not exceeding 35 years old with confirmed post caesarean section tubal adhesions (by diagnostic laparoscopy report or video CDs) as a solitary cause of their 2ry infertility.

Exclusion Criteria:

* patient's age \>35 years, male factor contribution, any ovulatory or endocrinological disorder, diagnosed any degree of endometriosis and patients with history of recurrent pregnancy loss. Couples with prolonged sexual abstinence for any reason will be excluded from participation in the study.

Primary outcomes:
measure: clinical pregnancy rate
timeFrame: After 1year
Secondary outcomes:
Other outcomes:
measure: Affordability
timeFrame: Within 1year
Locations:
city: Tanta
country: Egypt
facility: Ayman Shehata Dawood
state: Algharbia
Study officials:
affiliation: Lecturer at Tanta University
name: Ayman Dawood, MD
role: PRINCIPAL_INVESTIGATOR
References: