Dehydroepiandrosterone Maintain Mitochondrial Quality of Cumulus Cells in Poor Ovarian Responders

Not Applicable

Completed

• Conditions: Poor Responders; Dehydroepiandrosterone
• Interventions: Dietary Supplement: dehydroepiandrosterone (DHEA)

• Registration Number: NCT03438812
• Lead Sponsor: Kaohsiung Veterans General Hospital.

Brief Summary

To investigate whether the DHEA supplementation could improve mitochondrial quality in poor ovarian responders

Detailed Description

Women who underwent in vitro fertilization (IVF) treatment participated, including normal ovarian responders (NORs) and poor ovarian responders (PORs). PORs were assigned to receive DHEA supplementation or not before the IVF cycle. For all patients, cumulus cells (CCs) were obtained after oocyte retrieval. In the CCs, mRNA expression of mitochondria-related genes was measured. To compare the mRNA expression of mitochondria-related genes in the CCs among the three groups.

Study Timeline

• Study Start: 2017-09-06
• Study First Submitted: 2018-02-04
• Study First Submitted QC: 2018-02-17
• Study First Posted: 2018-02-20
• Primary Completion: 2019-12-31
• Study Completion: 2019-12-31
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-17
• Last Update Posted: 2021-02-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 66

Inclusion Criteria

• Poor ovarian responders met the Bologna criteria, having at least two of the three following features: (1) advanced maternal age (≥ 40 years) or any other risk factor for POR, (2) a previous POR (≤ 3 oocytes with a conventional stimulation protocol), and (3) an abnormal ovarian reserve test. An abnormal ovarian reserve test was defined as antral follicle counts (AFC) < 5 or anti-Müllerian hormone (AMH) < 1 ng/mL in this study.
• Normal ovarian responders met the following criteria: (1) AFCs ≥ 5 or AMH ≥ 1 ng/mL and (2) the number of retrieved oocytes was between 5 and 15.

Exclusion Criteria

• previous oophorectomy
• exposure to cytotoxic or pelvic irradiation for malignancy
• positive screening for recurrent pregnancy loss (chromosome mapping, antinuclear antibodies, extractable nuclear antigens, antiphospholipid antibodies, thrombophilic screening)
• any other sensitizing or ovarian stimulating therapy during the previous 3 months

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Poor ovarian responders with DHEA	dehydroepiandrosterone (DHEA)	Women who meet the Bologna criteria receive dehydroepiandrosterone (DHEA, 90 mg daily for two months at least) supplementation prior to the IVF cycle.

Primary Outcome Measures

Name	Time	Method
mitochondria related genes expression	through study completion, an average of 1 year	cumulus cells genes expression

Secondary Outcome Measures

Name	Time	Method
oocytes	through study completion, an average of 1 year	retrieved oocytes in number
pregnancy rate	pregnancy will be confirmed 4 weeks after embryo transfer	clinical pregnancy rate
embryos	numbers will be confirmed 3 days after fertilization	day 3 embryos in number

Trial Locations

Locations (1)

Kaohsiung Veterans General Hospital; 🇨🇳 Kaohsiung, Taiwan