Finding genetic signatures for unexplained infertility in wome

Not Applicable

• Conditions: Health Condition 1: N979- Female infertility, unspecified

• Registration Number: CTRI/2022/09/045889
• Lead Sponsor: Strand Life Sciences Private Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 29 April 2024

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1. Consenting female subjects aged between 21-35 years

2. Couples who have been trying to conceive for at least 1 year

3. Clinical diagnosis of unexplained infertility

4. Patients who have not conceived with 3 ART cycles (IUI or IVF) with donor gametes, if

partner is diagnosed with male factor infertility

5. Normal uterine cavity as visualised by 3-D ultrasound or hysteroscopy

6. At least one patent fallopian tube as evaluated by sonosalpingography or

hysterosalpingography or laparoscopy

Exclusion Criteria

1. Body mass index (BMI) =30 kg/m2

2. History of known structural anomalies of the uterus or cervical stenosis as established by

clinical examination and diagnostic procedures such as hysteroscopy or laparoscopy or

imaging

3. History of ovarian factor infertility as established by a diagnosis of PCOS, ovarian cysts

or tumours on ultrasound

4. Clinical history of irregular menstrual cycles or amenorrhea

5. History suggestive of poor ovarian reserve with an antral follicle count (AFC) of =5 on

day 2 or Anti-Mullerian Hormone levels (AMH) of <1.2 ng/mL at the time of diagnosis

at initial clinical presentation

6. History suggestive of uncontrolled thyroid disorder, uncontrolled diabetes mellitus or

hyperprolactinemia or clinically significant changes in hormones that may be associated

with infertility

7. Any abnormalities detected on ultrasound or hysterosalpingography or laparoscopy or

hysteroscopy that may be associated with infertility

8. Any prior medical or surgical treatments in female partner that may be associated with

infertility

9. History or lab investigations suggesting presence of STIs (HIV1/2, HBsAg, HCV)

10. Clinical history of infectious disease or autoimmune disease known to cause infertility

eg. Genital Tuberculosis, SLE

11. History of any known chromosomal defects or genetic disorders in the subject

12. History of any pregnancy in the past in subjects

13. History of recurrent pregnancy loss or miscarriages in the subject

14. History of male factor infertility, if the couple has not tried at least 3 cycles of ART (IUI

or IVF) with donor sperms

15. Any psychosexual causes in the couple which may result in a failure to conceive, if the couple has not undergone an assisted reproductive technology (IUI and IVF) based

treatment.

Study & Design

• Study Type: Observational
• Study Design: Not specified