Evidence map›Paper›PMID 25296654›Full record

Trial reportBMJ open2014

Efficacy of dehydroepiandrosterone to overcome the effect of ovarian ageing (DITTO): a proof of principle randomised controlled trial protocol.

Kannamannadiar Jayaprakasan, Amarin Narkwichean, Walid E Maalouf, Bruce K Campbell

Registry-linked trialAbstract readRandomized Controlled Trial
In one paragraph

Trial report in BMJ open, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01572025 (Efficacy of Dehydroepiandrosterone to Overcome the Effect of Ovarian Aging - A Pilot Double Blinded Randomised Controlled Trial), which is not on this map. Cited by 6 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed, 1 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT01572025 phase3completednot on this map

Efficacy of Dehydroepiandrosterone to Overcome the Effect of Ovarian Aging - A Pilot Double Blinded Randomised Controlled Trial

TypeinterventionalSponsorUniversity of NottinghamRan2012 to 2014Enrolled60ConditionsInfertility, Ovarian Aging, Diminished Ovarian Reserve (DOR), Predicted Poor-respondersArmsDehydroepiandrosterone, Placebo
3 · Its place in the literature

Who cites it

6 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Article
  3. Evaluation of Ovarian Reserve in Women With Rheumatoid Arthritis.Journal of family & reproductive health · 2021
    Article
  4. Article
  5. Article
  6. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

4 authors.

Kannamannadiar JayaprakasanDivision of Child Health, Obstetrics and Gynaecology, School of Medicine, Faculty of Medicine and Health Sciences, University of Nottingham, Nottingham, UK.
Amarin NarkwicheanDivision of Child Health, Obstetrics and Gynaecology, School of Medicine, Faculty of Medicine and Health Sciences, University of Nottingham, Nottingham, UK.
Walid E MaaloufDivision of Child Health, Obstetrics and Gynaecology, School of Medicine, Faculty of Medicine and Health Sciences, University of Nottingham, Nottingham, UK.
Bruce K CampbellDivision of Child Health, Obstetrics and Gynaecology, School of Medicine, Faculty of Medicine and Health Sciences, University of Nottingham, Nottingham, UK.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionDehydroepiandrosterone (DHEA) has been proposed to improve pregnancy rates in women with diminished ovarian reserve undergoing in vitro fertilisation (IVF) treatment. However, evidence regarding its efficacy is supported by a limited number of randomised controlled trials (RCTs). This double-blinded RCT aims to measure the effect of DHEA supplementation prior to and during controlled ovarian hyperstimulation on ovarian response prior to IVF treatment in women predicted to have poor ovarian reserve. METHODS AND ANALYSIS: Sixty women with ovarian antral follicle count ≤10 and serum anti-Mullerian hormone ≤5 pmol/L undergoing IVF/intracytoplasmic sperm injection (ICSI) treatment at the Nurture fertility clinic, Nottingham will be recruited. They will be randomised to either receive DHEA capsule 75 mg/day or placebo for at least 12 weeks before egg collection. All participants will undergo standard long down regulation protocol using human menopausal gonadotropin 300 IU/day. Serum samples and follicular fluids at the time of egg collection will be collected for hormonal immunoassays. For ICSI participants, cumulus cells stripped from oocyte will be collected for cumulus gene expression analyses regarding oocyte competence. Microdrops of oocyte culture media before the time of ICSI will be assessed for glucose, pyruvate and lactate utilisation. Embryo transfer will be performed on day 2, 3 or 5 based on the number and quality of the embryos available. Pregnancy will be defined as urine pregnancy test positive (biochemical pregnancy) and 6-8 weeks ultrasound scan with fetal heart beat (clinical pregnancy) and live birth. It is planned to perform the molecular and nutritional fingerprint analyses in batches after finishing the clinical phase of the study. ETHICS AND DISSEMINATION: The approval of the study was granted by the NHS Research Ethics Committee (Ref number NRES 12/EM/0002), the Medicines and Healthcare products Regulatory Agency (MHRA), and the Nottingham University Hospitals Trust Research and Development department. All participants shall provide written informed consent before being randomised into allocated treatment groups. TRIAL REGISTRATION NUMBER: Protocol V.2.0; EudraCT number: 2011-002425-21; http://www.clinicaltrials.gov; NCT01572025; CTA reference: 03057/0053/001-0002.

Indexed as

Ovarian ReserveAdultDehydroepiandrosteroneDouble-Blind MethodFemaleFertilization in VitroGene Expression ProfilingHormonesHumansOocyte RetrievalOocytesOvulation InductionPilot ProjectsTreatment OutcomeYoung AdultDehydroepiandrosteroneHormonesGYNAECOLOGY

Identifiers

PMID25296654
PMCPMC4194749

What OpenQuestion holds

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LicenceCC BY-NC
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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.