Non-surgical Interventions for Infertility in Endometriosis
- Conditions
- Infertility, FemaleEndometriosis
- Interventions
- Registration Number
- NCT06560814
- Lead Sponsor
- Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 18
- Women of reproductive age 18-35 yrs
- Women who are infertile or wish pregnancy
- Sonographic diagnosis of chocolate cyst with or without dysmenorrhea
- Women staying with her husband
- Recurrent endometrioma after previous surgery
- BMI at or more than 30 kg/m2
- Significant abnormalities in renal and liver function.
- Known male factor
- Use of investigational drugs or hormones, concomitant or in last 30 days.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Cabergoline Cabergoline plus timed intercourse Tab Cabergoline 0.5 mg twice weekly for 24 weeks, plus timed intercourse Dydrogesterone Dydrogesterone plus timed intercourse tab Dydrogesterone( 10 mg) twice daily from day 5 to day 25 of menstrual cycle for 24 weeks, plus timed intercourse
- Primary Outcome Measures
Name Time Method Pain reduction estimated by mean change on a Visual Analog Scale 24 weeks Mean change in Visual Analogue Score (1-10), higher score means worse outcome
Percentage change in size 24 weeks Percentage change in size (maximum diameter) of chocolate cyst assessed by transvaginal ultrasound at week 24
Pregnancy rate 24 weeks Proportion in each group of participants of those who conceive , biochemical (serum beta hCG \> 40 IU/mL) or clinical (sonographic appearance of gestational sac)
- Secondary Outcome Measures
Name Time Method Change in CA 125 24 weeks Serum CA 125 level will be measured in blood
Adverse effect 24 weeks From patient drug history
Trial Locations
- Locations (1)
Bangabandhu Sheikh Mujib Medical University
🇧🇩Dhaka, Bangladesh