Infertility Clinical Trial
— DITTOOfficial title:
Efficacy of Dehydroepiandrosterone to Overcome the Effect of Ovarian Aging - A Pilot Double Blinded Randomised Controlled Trial
- To test the hypothesis that supplementation of DHEA for at least twelve weeks prior to
and during ovarian stimulation increases oocyte quantity (number of oocytes retrieved)
and oocyte quality (clinical pregnancy rates and molecular markers) following IVF and
IVF/ICSI treatment.
- To evaluate the feasibility of conducting a large multicentre trial
Status | Completed |
Enrollment | 60 |
Est. completion date | December 2014 |
Est. primary completion date | December 2014 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 23 Years to 48 Years |
Eligibility |
Inclusion Criteria: - Women aged above 23 years with diminished ovarian reserve (predicted to be poor-responder), defined as antral follicle count <10 and/or Anti-Mullerian hormone <5pmol/L - Women undergoing IVF and IVF/ICSI treatment - Women must have a regular spontaneous menstrual cycle of 21 - 35 days Exclusion Criteria: - Women with BMI >35 Kg/M2 - Women with a single ovary - Women with untreated hydrosalpinx/ submucous fibroid/ endometrial polyp at the start of treatment - Women with any history of seizure disorders - Women with previous participation in this trial in an earlier treatment cycle - Women with any known endocrine disorders such as congenital adrenal hyperplasia, thyroid diseases, hyperprolactinemia - Known allergy to DHEA - Diabetic women on insulin as insulin lowers DHEA levels and might reduce the effectiveness of DHEA supplements. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United Kingdom | Nottingham University Research and Treatment Unit in Reproduction (NURTURE) | Nottingham | Nottinghamshire |
Lead Sponsor | Collaborator |
---|---|
University of Nottingham |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of oocytes retrieved | Oocytes retrieved within 15 weeks after DHEA/placebo supplementations. | within 15 weeks after DHEA/Placebo supplementation | No |
Primary | Feasibility to conduct a large multicentre randomised controlled trial | Feasibility is evaluated by assessing recruitment rates and compliance of the recruited participants with DHEA/ placebo intake and follow up rates | with in 20 weeks of the research period (per participant) | No |
Secondary | Oocyte quality (clinical and molecular markers) | Clinical pregnancy rates (Pregnancy rate determined at week 5 to 7 after embryo transfer). Molecular markers of oocyte quality as assessed by expression of cumulus cell molecular markers of oocyte competence and also by assessing energy consumption (pyruvate, lactate and glucose utilization) from the media by the oocytes and embryos (nutritional finger printing) |
The sample is collected at 14-16 weeks after recruitment and assessment is performed at one year. | No |
Secondary | Aneuploidy rates in the immature oocytes and unfertilized oocytes using microarray technology | The sample is collected at 14-16 weeks after recruitment and assessment is performed at one year. | No |
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