Clinical trial NCT06560814: Non-surgical Interventions for Infertility in Endometriosis
Official title: Non-surgical Interventions for Infertility in Endometriosis: A Parallel-Design Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Endometriosis
Infertility, Female
Keywords: endometriosis
Lead sponsor: Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
Sponsor class: OTHER
First posted: 2024-08-19
Enrollment: 18
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Open label, Parallel design randomized clinical trial
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Pain reduction estimated by mean change on a Visual Analog Scale
timeFrame: 24 weeks
measure: Percentage change in size
timeFrame: 24 weeks
measure: Pregnancy rate
timeFrame: 24 weeks
Secondary outcomes:
measure: Change in CA 125
timeFrame: 24 weeks
measure: Adverse effect
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Dhaka
country: Bangladesh
facility: Bangabandhu Sheikh Mujib Medical University
Study officials:
affiliation: Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
name: Shakeela Ishrat, FCPS Obgyn
role: PRINCIPAL_INVESTIGATOR
References: