Whole-genome Sequencing Study in Patients With Diminished Ovarian Reserve

NCT04711772 | Unknown

• 1 other identifier: NFEC-2020-188
• Study Type: observational
• Target: 140
• Locations: 1 country
• Sites: 1

Brief Summary

The study aims to explore the genetic pathogenesis of diminished ovarian reserve via whole-genome sequencing technology in Chinese women.

Conditions

Diminished Ovarian Reserve

Keywords

Diminished Ovarian Reserve; Whole-genome Sequencing

Outcome Measures

Primary Outcomes (1)

• Genotype

  Measure the genotype by whole-genome sequencing in all participates.

  1/9/2020-31/12/2022

Study Arms (2)

DOR group

Genomic DNA will be extracted from peripheral blood leukocytes to perform whole-genome sequencing in participates with diminished ovarian reserve.

Other: whole-genome sequencing

Control group

Participants with normal ovarian reserve will be recruited as control group and peripheral blood leukocytes genomic DNA will be extracted to perform whole-genome sequencing.

Other: whole-genome sequencing

Interventions

whole-genome sequencing OTHER

Whole-genome sequencing will be preformed for each participate to explore the potential disease-causing genes of DOR.

Control group; DOR group

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

The two groups of this study consist of DOR patients and women with normal ovarian reserve.

You may qualify if:

• DOR group:
• age between 18 and 40 years;
• number of oocytes obtained in previous ovarian stimulation cycles ≤3;
• bilateral ovarian antral follicle count (AFC) \< 5-7;
• serum anti-Mullerian hormone (AMH) \<0.5-1.1ng/ml.
• Control group:
• age between 18 and 40 years;
• bilateral AFC ≥8;
• serum AMH ≥1.2ng/ml;
• regular menstrual cycles occurring every 25-35 days.

You may not qualify if:

• an abnormal karyotype;
• a history of other endocrine diseases such as polycystic ovary syndrome, hyperprolactinemia and hyperthyroidism;
• a history of radiotherapy, chemotherapy and ovarian surgery.

Sponsors & Collaborators

• Nanfang Hospital, Southern Medical University: lead
• Ferring Pharmaceuticals: collaborator

Study Sites (1)

Center for Reproductive Medicine, Department of Gynecology and Obstetrics, Nanfang Hospital, Southern Medical University

Guangzhou, Guangdong, 510515, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Peripheral blood samples(10 ml) will be collected(in EDTA anticoagulant tube) and an informed consent form will be signed for participates diagnosed with DOR and control women.

MeSH Terms

Interventions

Whole Genome Sequencing

Intervention Hierarchy (Ancestors)

Sequence Analysis, DNA; Sequence Analysis; Genetic Techniques; Investigative Techniques

Study Officials

• Shi-ling Chen, M.D, Ph.D

  Nanfang Hospital, Southern Medical University

  STUDY DIRECTOR

Central Study Contacts

Shi-ling Chen, M.D, Ph.D

CONTACT

+86-020-62787604; chensl_92@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 13, 2021
• First Posted: January 15, 2021
• Study Start: September 1, 2020
• Primary Completion: June 30, 2022
• Study Completion: December 31, 2022
• Last Updated: January 15, 2021

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)