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Finding genetic signatures for unexplained infertility in women

Genetic profiling of women with infertility requiring assisted reproduction

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2022/09/045889
Enrollment
1000
Registered
2022-09-26
Start date
Unknown
Completion date
Unknown
Last updated
2025-02-03

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

Conditions

Health Condition 1: N979- Female infertility, unspecified

Interventions

None listed

Sponsors

Strand Life Sciences Private Limited
Lead Sponsor

Eligibility

Inclusion criteria

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

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 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.

Design outcomes

Primary

MeasureTime frame
Identification of a set of genes associated with female idiopathic infertility that can be used to shortlist genetic targets for development of non-hormonal, safe and effective female contraceptives.Timepoint: Single time point

Secondary

MeasureTime frame
Not ApplicableTimepoint: Not Applicable

Countries

India

Contacts

Public ContactVamsi Veeramachaneni

Strand Life Sciences Private Limited

vamsi@strandls.com

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026