EndometriosisPhase 2RCTNCT06560814
Non-surgical Interventions for Infertility in Endometriosis
A Phase 2 study testing Cabergoline plus timed intercourse and Dydrogesterone plus timed intercourse in people with Endometriosis and Infertility, Female, run by Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh at 1 site in Bangladesh.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women only
- Conditions the study is for
- Endometriosis, Infertility, Female
- What is being tested?
- Cabergoline plus timed intercourse and Dydrogesterone plus timed intercourse
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteBangladesh
- Study dates
- 1 Jul 2020to 30 Jun 2021
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Endometriosis, Infertility, Female
- Being tested
- Cabergoline plus timed intercourse, Dydrogesterone plus timed intercourse
- Keywords
- endometriosis
- Medical subject headings
- Endometriosis, Infertility, Female
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cabergoline plus timed intercourseDrug
Also called Cabergol
Cabergoline 0.5 mg tab orally twice weekly (fridays and tuesdays) after meal at night for 24 weeks plus intercourse timed with LH kit
Dydrogesterone plus timed intercourseDrug
Also called Progest
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
| Study group | Role | What they receive |
|---|---|---|
| Cabergoline | Experimental | Tab Cabergoline 0.5 mg twice weekly for 24 weeks, plus timed intercourse Receives: 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 Receives: Drug: Dydrogesterone plus timed intercourse |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain reduction estimated by mean change on a Visual Analog Scale
Mean change in Visual Analogue Score (1-10), higher score means worse outcome
Measured: 24 weeks
Percentage change in size
Percentage change in size (maximum diameter) of chocolate cyst assessed by transvaginal ultrasound at week 24
Measured: 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)
Measured: 24 weeks
Secondary outcomes (2)
Change in CA 125
Serum CA 125 level will be measured in blood
Measured: 24 weeks
Adverse effect
From patient drug history
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2024
- Study start1 Jul 2020
- Primary completion21 Jun 2021
- Study completion30 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EndometriosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Open label, Parallel design randomized clinical trial
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shakeela Ishrat, Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
- Investigators
- Shakeela Ishrat, FCPS Obgyn, Principal investigator, Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06560814
- Sponsor's protocol ID
- BSMMU/2021/06
- Acronym
- RCT
- Status last verified
- Aug 2024
- First submitted
- 11 Mar 2021
- Last updated
- 19 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-surgical Interventions for Infertility in Endometriosis: A Parallel-Design Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06560814
- Acronym / sponsor ID
- RCT / BSMMU/2021/06
- Conditions
- Endometriosis, Infertility, Female
- Keywords
- endometriosis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Bangabandhu Sheikh Mujib Medical University, Dhaka, BangladeshUniversity, hospital or other
- Study start
- 1 Jul 2020 (actual)
- Primary completion
- 21 Jun 2021 (actual)
- Study completion
- 30 Jun 2021 (actual)
- First posted
- 19 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Open label, Parallel design randomized clinical trial
| Arm | Type | Receives |
|---|---|---|
| Cabergoline | Experimental | Drug: Cabergoline plus timed intercourseTab Cabergoline 0.5 mg twice weekly for 24 weeks, plus timed intercourse |
| Dydrogesterone | Active comparator | Drug: Dydrogesterone plus timed intercoursetab Dydrogesterone( 10 mg) twice daily from day 5 to day 25 of menstrual cycle for 24 weeks, plus timed intercourse |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cabergoline plus timed intercourseAlso: CabergolCabergoline 0.5 mg tab orally twice weekly (fridays and tuesdays) after meal at night for 24 weeks plus intercourse timed with LH kit | Drug | Cabergoline |
| Dydrogesterone plus timed intercourseAlso: ProgestDydrogesterone 10 mg tab orally twice daily from day 5 to day 25 of menstrual cycle for 24 weeks plus intercourse timed with LH kit | Drug | Dydrogesterone |
Primary outcome
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
Percentage change in size
Time frame: 24 weeks
Percentage change in size (maximum diameter) of chocolate cyst assessed by transvaginal ultrasound at week 24
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)
2 secondary outcomes
Change in CA 125
Time frame: 24 weeks
Adverse effect
Time frame: 24 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shakeela Ishrat, FCPS Obgyn principal investigator
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Cabergoline plus timed intercourse and Dydrogesterone plus timed intercourse in people with Endometriosis and Infertility, Female, run by Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh at 1 site in Bangladesh.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Bangladesh. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain reduction estimated by mean change on a Visual Analog Scale (time frame: 24 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2024.