Endometriosis, Infertility, Female
Conditions
Keywords
endometriosis
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.
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.
Interventions
DRUGCabergoline 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
DRUGDydrogesterone 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
Sponsors
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Open label, Parallel design randomized clinical trial
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 35 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain reduction estimated by mean change on a Visual Analog Scale | 24 weeks | Mean change in Visual Analogue Score (1-10), higher score means worse outcome |
| Percentage change in size | 24 weeks | Percentage change in size (maximum diameter) of chocolate cyst assessed by transvaginal ultrasound at week 24 |
| Pregnancy rate | 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
| Measure | Time frame | Description |
|---|---|---|
| Change in CA 125 | 24 weeks | Serum CA 125 level will be measured in blood |
| Adverse effect | 24 weeks | From patient drug history |
Countries
Bangladesh
Outcome results
None listed