Ignite Creation Date:
2025-12-24 @ 2:55 PM
Ignite Modification Date:
2025-12-25 @ 2:02 PM
Study NCT ID:
NCT03476759
Status:
COMPLETED
Last Update Posted:
2021-11-29
First Post:
2018-03-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Laparoscopic Tubal Adhesiolysis Versus IVF-ICSI
Sponsor:
Tanta University
Organization:
Study Overview
Official Title:
Laparoscopic Tubal Adhesiolysis Versus IVF-ICSI in Cases of Post Caesarean Section Adhesions, Which is the Best?
Status:
COMPLETED
Status Verified Date:
2021-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?: