nderstanding reasons behind fewer pregnancies in Indian women suffering from endometriosis and adenomyosis; and finding appropriate treatment to improve it

Not Applicable

• Conditions: Health Condition 1: N972- Female infertility of uterine originHealth Condition 2: N972- Female infertility of uterine originHealth Condition 3: N719- Inflammatory disease of uterus, unspecified

• Registration Number: CTRI/2019/01/016919
• Lead Sponsor: Institute Of Reproductive Medicine

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 17 October 2022

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

Women with Grade III and Grade IV endometriosis and adenomyosis of 25-40 years with regular menstrual cycles (25-32 days), euthyroid with normal baseline hormone levels will be included.

Exclusion Criteria

Women with stage I and II endometriosis, fibroids, hydrosalpinx, uterine size >12 weeks, uterine abnormalities, follicle stimulating hormone (FSH) >12 IU/ml, polycystic ovary syndrome, any pelvic pathology including pelvic inflammatory disease and adhesions and male factor infertility will be excluded

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
A. To evaluate VAS and PBAC of patients suffering from symptomatic adenomyosis with or without endometriosis, before and after the treatment. <br/ ><br>B. To evaluate and compare the Live birth following different treatment strategies. <br/ ><br>C. To evaluate the molecular markers of implantation in these patients and compare them with controls, before and after treatments. <br/ ><br>1. Aromatase Enzyme <br/ ><br>2. Estrogen receptor-alpha and beta receptor <br/ ><br>3. Progesterone Receptor <br/ ><br>4. VEGF <br/ ><br>5. eNOS <br/ ><br>Timepoint: VAS & PBAC: May 2022 - May 2023 <br/ ><br>Molecular Marker Assessment: June 2022 - June 2023 <br/ ><br>Live Birth : June 2023 - May 2024 <br/ ><br>

Secondary Outcome Measures

Name	Time	Method
A. To evaluate the sonographic features of adenomyosis, before and after treatment. <br/ ><br>B. To evaluate and compare biochemical pregnancy rate, clinical pregnancy rate and miscarriage rate.Timepoint: Sonographic Feature assessments: May 2022 - June 2023 <br/ ><br> <br/ ><br>Reproductive outcome: September 2022 - September 2023