Non-surgical Interventions for Infertility in Endometriosis

NCT ID: NCT06560814

Last Updated: 2024-08-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-07-01
• Study Completion Date: 2021-06-30

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 (0.5 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 intercourse).The 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 0.5 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.

Conditions

Endometriosis; Infertility, Female

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Cabergoline

Tab Cabergoline 0.5 mg twice weekly for 24 weeks, plus timed intercourse

Group Type: EXPERIMENTAL

Cabergoline plus timed intercourse

Intervention Type: DRUG

Cabergoline 0.5 mg tab orally twice weekly (fridays and tuesdays) after meal at night for 24 weeks plus intercourse timed with LH kit

Dydrogesterone

tab Dydrogesterone( 10 mg) twice daily from day 5 to day 25 of menstrual cycle for 24 weeks, plus timed intercourse

Group Type: ACTIVE_COMPARATOR

Dydrogesterone plus timed intercourse

Intervention Type: DRUG

Dydrogesterone 10 mg tab orally twice daily from day 5 to day 25 of menstrual cycle for 24 weeks plus intercourse timed with LH kit

Interventions

Cabergoline plus timed intercourse

Cabergoline 0.5 mg tab orally twice weekly (fridays and tuesdays) after meal at night for 24 weeks plus intercourse timed with LH kit

Intervention Type: DRUG

Dydrogesterone plus timed intercourse

Dydrogesterone 10 mg tab orally twice daily from day 5 to day 25 of menstrual cycle for 24 weeks plus intercourse timed with LH kit

Intervention Type: DRUG

Other Intervention Names

Cabergol; Progest

Eligibility Criteria

Inclusion Criteria

1. Women of reproductive age 18-35 yrs

2. Women who are infertile or wish pregnancy

3. Sonographic diagnosis of chocolate cyst with or without dysmenorrhea

4. Women staying with her husband

Exclusion Criteria

1. Recurrent endometrioma after previous surgery

2. BMI at or more than 30 kg/m2

3. Significant abnormalities in renal and liver function.

4. Known male factor

5. Use of investigational drugs or hormones, concomitant or in last 30 days.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

OTHER

Sponsor Role: lead

Responsible Party

Shakeela Ishrat

Associate Professor, Department of Reproductive Endocrinology & Infertility

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Shakeela Ishrat, FCPS Obgyn

Role: PRINCIPAL_INVESTIGATOR

Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

Locations

Bangabandhu Sheikh Mujib Medical University

Dhaka, , Bangladesh

Countries

Bangladesh

Other Identifiers

BSMMU/2021/06

Identifier Type: -

Identifier Source: org_study_id