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

Understanding molecular mechanism of Implantation Failure in Women with Endometriosis and Adenomyosis Undergoing In-vitro Fertilization and Methods to Improve their Fertility Outcomes

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2019/01/016919
Enrollment
210
Registered
2019-01-04
Start date
Unknown
Completion date
Unknown
Last updated
2022-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

Intervention1: Letrozole: Patients will be given oral dose of Letrozole 2.5 mg thrice weekly for 3 months. Sonographic features of adenomyosis will be assessed before and after 3 months of treatment.

Sponsors

Institute Of Reproductive Medicine
Lead Sponsor

Eligibility

Inclusion criteria

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

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

Design outcomes

Primary

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

Secondary

MeasureTime frame
A. To evaluate the sonographic features of adenomyosis, before and after treatment. B. To evaluate and compare biochemical pregnancy rate, clinical pregnancy rate and miscarriage rate.Timepoint: Sonographic Feature assessments: May 2022 - June 2023 Reproductive outcome: September 2022 - September 2023—

Countries

India

Contacts

Public ContactSunita Sharma

Institute of Reproductive Medicine

bncirm@gmail.com03323215125

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 12, 2026