Non-surgical Interventions for Infertility in Endometriosis

NCT06560814 | Completed Phase 2

• 1 other identifier: BSMMU/2021/06
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Endometriosis; Infertility, Female

Keywords

endometriosis

Outcome Measures

Primary Outcomes (3)

• Pain reduction estimated by mean change on a Visual Analog Scale

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

  24 weeks

• Percentage change in size

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

  24 weeks

• Pregnancy rate

  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 Outcomes (2)

• Change in CA 125

  24 weeks

• Adverse effect

  24 weeks

Study Arms (2)

Cabergoline

EXPERIMENTAL

Tab Cabergoline 0.5 mg twice weekly for 24 weeks, plus timed intercourse

Drug: Cabergoline plus timed intercourse

Dydrogesterone

ACTIVE COMPARATOR

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

Interventions

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

Also known as: Cabergol

Cabergoline

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

Also known as: Progest

Dydrogesterone

Eligibility Criteria

• Age: 18 Years - 35 Years
• Gender Eligibility Details: women
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh: lead

Study Sites (1)

Bangabandhu Sheikh Mujib Medical University

Dhaka, 1200, Bangladesh

Location

MeSH Terms

Conditions

Endometriosis; Infertility, Female

Interventions

Cabergoline; Dydrogesterone; Progest

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Infertility

Intervention Hierarchy (Ancestors)

Ergolines; Ergot Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Shakeela Ishrat, FCPS Obgyn

  Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Department of Reproductive Endocrinology & Infertility

Model Details: Open label, Parallel design randomized clinical trial

Study Record Dates

• First Submitted: March 11, 2021
• First Posted: August 19, 2024
• Study Start: July 1, 2020
• Primary Completion: June 21, 2021
• Study Completion: June 30, 2021
• Last Updated: August 19, 2024

Record last verified: 2024-08

Locations

BA (1)