Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06560814
Status:
COMPLETED
Last Update Posted:
None
First Post:
2021-03-11
Brief Title:
Non-surgical Interventions for Infertility in Endometriosis
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Non-surgical Interventions for Infertility in Endometriosis A Parallel-Design Randomized Clinical Trial
Status:
COMPLETED
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
RCT
Brief Summary:
A parallel design randomized clinical trial was carried out on 18 women with clinically diagnosed endometriosis who wish pregnancy in the Department of Reproductive Endocrinology and Infertility Bangabandhu Sheikh Mujib Medical University BSMMU Shahbag Dhaka Those who voluntarily provide consent to participate in this study will be randomly allocated to one of the two treatment arms Allocation concealment will be done by sequentially numbered sealed envelopes The arms and interventions are cabergoline 05 mg twice weekly for 6 months plus timed intercourse and dydrogesteron 20 mg daily from day 5 to day 25 of menstrual cycle for 6 months plus timed intercourseThe women will be assessed by telephone interview at monthly intervals TVS and serum Ca 125 at 3 months and 6 months
Detailed Description:
Infertile women with endometriosis will be recruited from those attending Dept of Reproductive Endocrinology and Infertility after clinical diagnosis on the basis of sonographic findings of chocolate cyst with or without dysmenorrhea After evaluating for eligibility criteria and taking informed consent she will be randomized to either cabergoline group or to dydrogesterone group Women assigned to cabergoline group will receive 05 mg cabergoline twice weekly fridays and tuesdays after meal at night for 6 months The dydrogesterone group will receive 10 mg of dydrogesterone twice daily from day 5 to day 25 of menstrual cycle for six months She will be followed up every month to check for compliance or any side effects The couple will have intercourse timed with LH kit or intercourse on alternate days from day 10 to day 15 of the cycle if the LH kit is not available She will visit 3 months and 6 months after the beginning of treatment At each follow up visit she will be assessed for pregnancy visual analog scale for pain and transvaginal sonogram to measure the chocolate cyst Estimation of serum CA125 and any side effects will be noted
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None