Effectiveness of Adjuvant Supplements Prior to in IVF

Study Overview
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Brief Summary
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To investigate the effect of combined DHEA, CoQ10 and tocotrienol on IVF cycles in poor ovarian responders

Detailed Description
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Background There is a trend for delayed marriage and childbearing worldwide. Women undergoing in vitro fertilization (IVF) cycles are getting older. Women with advanced age are more likely to be poor ovarian responders (PORs) who have poor prognosis in IVF cycles. Numerous studies have shown that DHEA supplementation may improve IVF outcomes in PORs. Additionally, due to poor prognosis of PORs, it is quite common to combine multiple therapies instead of just one treatment. Some studies showed that CoQ10 and tocotrienol are beneficial for fertility. Thus, the aim of this study is to investigate the effect of combined DHEA, CoQ10 and tocotrienol on IVF cycles in PORs. Objective To investigate the effect of combined DHEA, CoQ10 and Tocotrienol on PORs undergoing IVF cycles Methods The study will be conducted from March 1st, 2022 to December 31st, 2023 in our reproductive center. We plan to enroll 120 PORs undergoing IVF cycles and divided them into four groups: (1) DHEA (n=30): 75 mg DHEA supplementation per day for three months; (2) DHEA + CoQ10 + Tocotrienol (n=30): 75 mg DHEA supplementation + 30 mg CoQ10 + 300 mg Tocotrienol per day for three months; (3) Control: no supplementation. Basic characteristics, infertility history, hormone profiles and ovarian reserve will be recorded. We will recheck serum levels of DHEA-S, FSH and AMH after DHEA supplementation. Then, during the IVF cycles, cumulus cells will be collected after oocyte retrieval to analyze genes expression and mitochondrial function. We will follow reproductive outcomes after embryo transfer. Outcome The effect of combined DHEA, CoQ10 and Tocotrienol on cumulus cells and IVF outcomes in PORs

Official Title
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To Investigate the Effectiveness of Adjuvant Supplements Prior to in Vitro Fertilization Cycles

Conditions
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Dietary Supplements

Intervention / Treatment
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* Dietary Supplement: DHEA
* Dietary Supplement: DHEA+CoQ10+Tocotrienol


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 35 44 BMI18 30 kg/m2 Diminished ovarian reserve (AFC<5, AMH<1.2 ng/ml) Exclusion Criteria: Primary ovarian insufficiency Congenital uterine anomaly Severe intrauterine adhesion Severe male factor Chromosome anomaly Malignancy Donor cycle having supplementation within 3 months

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 44 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 |
| --- | --- |
| Sham Comparator: DHEA group<br>75 mg DHEA supplementation per day for 3 months before IVF | Dietary Supplement: DHEA<br>* 75 mg DHEA supplementation per day for 3 months before IVF<br>|
| Experimental: DHEA+CoQ10+Tocotrienol group<br>75 mg DHEA supplementation + 30 mg CoQ10 + 300 mg Tocotrienol per day for 3 months before IVF | Dietary Supplement: DHEA+CoQ10+Tocotrienol<br>* 75 mg DHEA supplementation + 30 mg CoQ10 + 300 mg Tocotrienol per day for 3 months before IVF<br>|
| No Intervention: Control group<br>No supplementation before IVF | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ongoing pregnancy rate | continuous presence of a fetal heartbeat over 12 weeks of a pregnancy | through study completion, an average of 1.75 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical pregnancy rate | the presence of a fetal heartbeat at 6-7 weeks of a pregnancy | through study completion, an average of 1.75 year | 
| mitochondrial function of cumulus cells | Oxygen consumption rate of cumulus cells | through study completion, an average of 1.75 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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DHEA, CoQ10, Tocotrienol, poor ovarian responder, in vitro fertilization