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Completed

NCT Number: NCT06560814

Non-surgical Interventions for Infertility in Endometriosis

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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Key information

Age range

18 year–35 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Bangabandhu Sheikh Mujib Medical University

Dhaka, 1200, Bangladesh

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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.

Treatment and study plan

Cabergoline plus timed intercourse

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

Other names: Cabergol

Dydrogesterone plus timed intercourse

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

Other names: Progest

Primary outcomes

  1. Pain reduction estimated by mean change on a Visual Analog Scale

    Time frame: 24 weeks

    Mean change in Visual Analogue Score (1-10), higher score means worse outcome

  2. Percentage change in size

    Time frame: 24 weeks

    Percentage change in size (maximum diameter) of chocolate cyst assessed by transvaginal ultrasound at week 24

  3. Pregnancy rate

    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)

Secondary outcomes

  1. Change in CA 125

    Time frame: 24 weeks

    Serum CA 125 level will be measured in blood

  2. Adverse effect

    Time frame: 24 weeks

    From patient drug history

Sponsors and collaborators

Lead sponsor

Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

Other

Registry information

Official study title

Non-surgical Interventions for Infertility in Endometriosis: A Parallel-Design Randomized Clinical Trial

Acronym: RCT

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Aug 19, 2024
Registry last updated
Aug 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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