Clinical trial · Observational

IVF Outcome in Polycystic Ovary Syndrome Patients

Identification of Recent Biomarkers in Polycystic Ovary Syndrome Patients as a Predictors of IVF Outcome

NCT04104958CI-TRIAL-00042680unknownClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

1. To investigate the circulating concentrations of phoenixin and their associations with BMI, the concentrations of sex hormones including (LH), (FSH), (E2), (P4), (TT) and steroid hormones enzyme in PCOS patients. 2. To detect the expression PNX and humanin in women with or without PCOS and to elucidate possible correlations with ovarian reserve and clinical outcomes after IVF-ICSI. 3. To investigate relationship between PNX, humanin expression and PI3K/AKT/mTOR and autophagy pathway as a major signaling mechanism in PCOS for targeting new prognostic and therapeutic markers. 4. The study investigates the correlation between oocyte maturity, fertilization, recent biomarkers and a variety of hormonal parameters in follicular fluid.

Conditions

Conditions (1)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Polycystic Ovary Syndrome	—	UNRESOLVED	—

Interventions

Interventions (1)

Intervention	Type	Mapped drug	Match
qRTPCR (mRNA level).	Genetic	—	UNRESOLVED

Design

Arms and outcomes

Arms (2)

label
Group 1
description
Group 1 (n=50): women (age 20-40year) with PCOS who are diagnosed according to the criteria of the Rotterdam ESHRE/ASRM-sponsored PCOS consensus workshop group (2003), which require two of the following 3 manifestations: 1. oligo- or anovulation, 2. clinical and/or biochemical signs of hyperandrogenism (\> 2.08 nmol/l), 3. polycystic ovaries on ultrasound examination (the presence of ≥12 follicles measuring 2-9 mm in diameter and/or ovarian volume \> 10 cm)
interventionNames
1. Genetic: qRTPCR (mRNA level).
label
Group 2
description
Group 2 (n=50): women (age 20-40 year) with male factor infertility.
interventionNames
1. Genetic: qRTPCR (mRNA level).

Primary outcomes (2)

measure
Detect difference in expression of phoenixin and humanin in PCOS
timeFrame
Baseline

Eligibility

Eligibility (as posted)

Sex: Female
Minimum age: 20 Years
Maximum age: 40 Years

Show eligibility criteria text

Inclusion Criteria:

* • The diagnosis included donors, male factor infertility and PCOS women.

  * Age ranging from 20 to 40 years

Exclusion Criteria:

* • There were no other etiologies for the PCOS cases, such as congenital adrenal hyperplasia, 21-hydroxylase deficiency, androgen-secreting tumors, Cushing's syndrome, thyroid disease, and hyperprolactinemia.

  * Patients with endometriosis.
  * Patients with history of coronary artery disease, hypertension, liver cirrhosis or hematologic disorders.

References

Publications (4)

BACKGROUNDRao M, Zhou F, Tang L, Zeng Z, Hu S, Wang Y, Ke D, Cheng G, Xia W, Zhang L, Zhu C. Follicular fluid humanin concentration is related to ovarian reserve markers and clinical pregnancy after IVF-ICSI: a pilot study. Reprod Biomed Online. 2019 Jan;38(1):108-117. doi: 10.1016/j.rbmo.2018.11.002. Epub 2018 Nov 23. PMID 30503199
BACKGROUNDNguyen XP, Nakamura T, Osuka S, Bayasula B, Nakanishi N, Kasahara Y, Muraoka A, Hayashi S, Nagai T, Murase T, Goto M, Iwase A, Kikkawa F. Effect of the neuropeptide phoenixin and its receptor GPR173 during folliculogenesis. Reproduction. 2019 Jul;158(1):25-34. doi: 10.1530/REP-19-0025. PMID 30933929
BACKGROUNDAvagliano L, Terraneo L, Virgili E, Martinelli C, Doi P, Samaja M, Bulfamante GP, Marconi AM. Autophagy in Normal and Abnormal Early Human Pregnancies. Reprod Sci. 2015 Jul;22(7):838-44. doi: 10.1177/1933719114565036. Epub 2014 Dec 28. PMID 25544676
BACKGROUNDBozdag G, Mumusoglu S, Zengin D, Karabulut E, Yildiz BO. The prevalence and phenotypic features of polycystic ovary syndrome: a systematic review and meta-analysis. Hum Reprod. 2016 Dec;31(12):2841-2855. doi: 10.1093/humrep/dew218. Epub 2016 Sep 22. PMID 27664216