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Laparoscopic Tubal Adhesiolysis Versus IVF-ICSI

T

Tanta University

Status

Completed

Conditions

Tubal Factor Infertility

Treatments

Drug: IVF/ICSI
Procedure: Tubal adhesiolysis

Study type

Interventional

Funder types

Other

Identifiers

NCT03476759
Tanta University

Details and patient eligibility

About

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

Full 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

Enrollment

300 patients

Sex

Female

Ages

20 to 35 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

300 participants in 2 patient groups

Tubal adhesiolysis
Active Comparator group
Description:
laparoscopic tubal adhesiolysis and\\or tuboplasty
Treatment:
Procedure: Tubal adhesiolysis
IVF/ICSI
Active Comparator group
Description:
These patients will undergo IVF/ICSI
Treatment:
Drug: IVF/ICSI

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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