Bangabandhu Sheikh Mujib Medical University
Dhaka, 1200, Bangladesh
NCT Number: NCT06560814
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.
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Notify Me18 year–35 year
Female
Interventional
Phase 2
Dhaka, 1200, Bangladesh
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Cabergoline 0.5 mg tab orally twice weekly (fridays and tuesdays) after meal at night for 24 weeks plus intercourse timed with LH kit
Other names: Cabergol
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
Other names: Progest
Time frame: 24 weeks
Mean change in Visual Analogue Score (1-10), higher score means worse outcome
Time frame: 24 weeks
Percentage change in size (maximum diameter) of chocolate cyst assessed by transvaginal ultrasound at week 24
Time frame: 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)
Time frame: 24 weeks
Serum CA 125 level will be measured in blood
Time frame: 24 weeks
From patient drug history
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
Other
Non-surgical Interventions for Infertility in Endometriosis: A Parallel-Design Randomized Clinical Trial
Acronym: RCT
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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