Non-surgical Interventions for Infertility in Endometriosis (RCT)

August 15, 2024 updated by: Shakeela Ishrat, Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

18

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Bangladesh
      • Dhaka, Bangladesh, 1200
        • Bangabandhu Sheikh Mujib Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cabergoline
Tab Cabergoline 0.5 mg twice weekly for 24 weeks, plus timed intercourse
Drug: 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
Other Names:
  • Cabergol
Active Comparator: Dydrogesterone
tab Dydrogesterone( 10 mg) twice daily from day 5 to day 25 of menstrual cycle for 24 weeks, plus timed intercourse
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
Other Names:
  • Progest

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
24 weeks
Percentage change in size
Time Frame: 24 weeks
Percentage change in size (maximum diameter) of chocolate cyst assessed by transvaginal ultrasound at week 24
24 weeks
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)
24 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in CA 125
Time Frame: 24 weeks
Serum CA 125 level will be measured in blood
24 weeks
Adverse effect
Time Frame: 24 weeks
From patient drug history
24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

Investigators

  • Principal Investigator: Shakeela Ishrat, FCPS Obgyn, Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2020

Primary Completion (Actual)

June 21, 2021

Study Completion (Actual)

June 30, 2021

Study Registration Dates

First Submitted

March 11, 2021

First Submitted That Met QC Criteria

August 15, 2024

First Posted (Actual)

August 19, 2024

Study Record Updates

Last Update Posted (Actual)

August 19, 2024

Last Update Submitted That Met QC Criteria

August 15, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BSMMU/2021/06

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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