Dehydroepiandrosterone Maintain Mitochondrial Quality of Cumulus Cells in Poor Ovarian Responders

Study Overview
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Brief Summary
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To investigate whether the DHEA supplementation could improve mitochondrial quality in poor ovarian responders

Detailed Description
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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.

Official Title
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The Role of Dehydroepiandrosterone in the Maintenance of Mitochondrial Quality of Cumulus Cells in Poor Ovarian Responders

Conditions
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Dehydroepiandrosterone, Poor Responders

Intervention / Treatment
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* Dietary Supplement: dehydroepiandrosterone (DHEA)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Poor ovarian responders with DHEA<br>Women who meet the Bologna criteria receive dehydroepiandrosterone (DHEA, 90 mg daily for two months at least) supplementation prior to the IVF cycle. | Dietary Supplement: dehydroepiandrosterone (DHEA)<br>* Participants take DHEA 90 mg daily for two months at least before in vitro fertilization cycles.<br>|
| No Intervention: Poor ovarian responders<br>Women who meet the Bologna criteria undergo the IVF cycle without pretreatment with DHEA | |
| No Intervention: Normal ovarian responders<br>Women who do not meet the Bologna criteria and have normal ovarian response to ovarian stimulation. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| mitochondria related genes expression | cumulus cells genes expression | through study completion, an average of 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| oocytes | retrieved oocytes in number | through study completion, an average of 1 year | 
| embryos | day 3 embryos in number | numbers will be confirmed 3 days after fertilization | 
| pregnancy rate | clinical pregnancy rate | pregnancy will be confirmed 4 weeks after embryo transfer |