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| ID | Type | Description | Link |
|---|---|---|---|
| 2011-002425-21 | EudraCT Number |
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The purpose of this study is to evaluate the role of DHEA in counteracting the effects of ovarian ageing in an in-vitro fertilization (IVF) model. The study will examine whether the use of DHEA could improve clinical pregnancy rates following IVF treatment in women predicted to have aged ovaries by increasing oocyte quantity (ovarian response to gonadotrophins) and/ or by improving oocyte quality. The oocyte quality will be assessed by morphological and molecular markers.
This study will provide a mechanistic framework for translational research on mechanisms of ovarian ageing and drug interventions to slow down the ovarian ageing process and subsequent adverse physical and psychological consequences. Further, the data that will be produced from this research will have the potential to influence clinical practice in fertility clinics worldwide.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DHEA supplementation | Experimental |
| |
| Control | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dehydroepiandrosterone | Drug | Dehydroepiandrosterone (DHEA)(St Mary's Pharmaceutical Unit Cardiff and Vale) DHEA 75 mg capsule. 1 capsule taken once daily for at least 12 weeks prior commencing ovarian stimulation protocol : Stimulation protocol standard long down-regulation protocol, using human menopausal gonadotropin (HMG) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of oocytes retrieved | Oocytes retrieved within 15 weeks after DHEA/placebo supplementations. | within 15 weeks after DHEA/Placebo supplementation |
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kannamannadiar Jayaprakasan, MRCOG,PhD. | Division of Obstetrics and Gynaecology, School of Clinical Sciences, University of Nottingham | Principal Investigator |
| Bruce Campbell, PhD, DSc | University of Nottingham | Study Director |
| Nick Raine-Fenning, MRCOG, PhD | University of Nottingham | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nottingham University Research and Treatment Unit in Reproduction (NURTURE) | Nottingham | Nottinghamshire | NG7 2UH | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25296654 | Derived | Jayaprakasan K, Narkwichean A, Maalouf WE, Campbell BK. Efficacy of dehydroepiandrosterone to overcome the effect of ovarian ageing (DITTO): a proof of principle randomised controlled trial protocol. BMJ Open. 2014 Oct 8;4(10):e005767. doi: 10.1136/bmjopen-2014-005767. |
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| ID | Term |
|---|---|
| D007246 | Infertility |
| ID | Term |
|---|---|
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| D003687 | Dehydroepiandrosterone |
| ID | Term |
|---|---|
| D000737 | Androstenols |
| D000736 | Androstenes |
| D000731 | Androstanes |
| D013256 | Steroids |
| D000072473 |
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| Placebo | Drug | Matched Placebo containing no active ingredient. 1 capsule taken once daily for at least 12 weeks prior commencing ovarian stimulation protocol : Stimulation protocol standard long down-regulation protocol, using human menopausal gonadotropin (HMG) |
|
| The sample is collected at 14-16 weeks after recruitment and assessment is performed at one year. |
| 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. |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D015068 | 17-Ketosteroids |
| D007664 | Ketosteroids |
| D000305 | Adrenal Cortex Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D045165 | Testosterone Congeners |
| D012739 | Gonadal Steroid Hormones |
| D042341 | Gonadal Hormones |