Dehydroepiandrosterone (DHEA) Intervention To Treat Ovarian Aging

NCT01572025 | Completed Phase 3 DMC

• 2 other identifiers: 110542011-002425-21
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

• 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

Conditions

Infertility; Ovarian Aging; Diminished Ovarian Reserve (DOR); Predicted Poor-responders

Outcome Measures

Primary Outcomes (2)

• 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)

Secondary Outcomes (2)

• Oocyte quality (clinical and molecular markers)

  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.

Study Arms (2)

DHEA supplementation

EXPERIMENTAL

Drug: Dehydroepiandrosterone

Control

PLACEBO COMPARATOR

Drug: Placebo

Interventions

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)

DHEA supplementation

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)

Control

Eligibility Criteria

• Age: 23 Years - 48 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Nottingham: lead

Study Sites (1)

Nottingham University Research and Treatment Unit in Reproduction (NURTURE)

Nottingham, Nottinghamshire, NG7 2UH, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 25296654 DERIVED

MeSH Terms

Conditions

Infertility

Interventions

Dehydroepiandrosterone

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Androstenols; Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; 17-Ketosteroids; Ketosteroids; Adrenal Cortex Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Testosterone Congeners; Gonadal Steroid Hormones; Gonadal Hormones

Study Officials

• 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

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 19, 2012
• First Posted: April 5, 2012
• Study Start: May 1, 2012
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: December 9, 2015

Record last verified: 2015-12

Locations

GB (1)