Women having low ovarian reserve undergoing IVF/ICSI treatment
Conditions
Interventions
Product Name: Dehydroepiandrosterone
Pharmaceutical Form: Capsule
INN or Proposed INN: Dehydroepiandrosterone
Concentration unit: mg/g milligram(s)/gram
Concentration type: not less then
Concentration
Sponsors
University of Nottingham
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Women aged =23 years with diminished ovarian reserve Antral follicle count of =10 or Anti-Mullerian hormone levels =65 years) no F.1.3.1 Number of subjects for this age range 0
Exclusion criteria
Exclusion criteria: 1. BMI >35 Kg/M2 2. Women with a single ovary 3. Untreated hydrosalpinx/ submucous fibroid/ Endometrial polyp at the start of treatment 4. Any history of seizure disorders 5. Previous participation in this trial in an earlier treatment cycle 6. Any known endocrine disorders such as congenital adrenal hyperplasia, thyroid diseases, hyperprolactinemia 7. Known allergy to DHEA 8. Diabetic women on insulin (Insulin lower the DHEA levels and might lower the effectiveness of DHEA supplements)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: • To examine whether supplementation of DHEA for at least twelve weeks prior to and during ovarian stimulation increases the number of oocytes retrieved and the clinical pregnancy rates following IVF/ICSI treatment. • To evaluate the feasibility of conducting a large multicentre randomised controlled trial of DHEA versus Placebo in women affected with ovarian ageing undergoing IVF/ICSI treatment.;Secondary Objective: • To examine the effect of DHEA on developmental competence of oocytes as measured by molecular markers 1. Expression levels of a panel of 9 cumulus markers of oocyte competence: FSH-R, LH-R, pentraxin 3, cyclooxygenase 2, hyaluronic acid synthase 2, the BMP antagonist-Gremlin, epidermal growth factor (EGF)-like signalling molecules amphiregulin, epiregulin and betacellulin; 2. Nutritional finger printing: measuring glucose, pyruvate and lactate utilization from the culture media as the energy consumption by the oocyte from the medium vary depending on its ability to develop to the blastocyst stage) • To examine the effect of DHEA on chromosomal anomalies (aneuploidy rates) in immature and unfertilized oocytes.;Primary end point(s): • Number of oocytes retrieved and clinical pregnancy rates • Recruitment rates, compliance of recruited participants with DHEA/ Placebo intake and follow up rates;Timepoint(s) of evaluation of this end point: The last time point to obtain all the primary outcome measures would be when the pregnant participant has their early pregnancy scan following IVF/ICSI treatment. i.e. about 20 weeks after they entered into the trial. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Expression levels of a panel of 9 cumulus markers of oocyte competence: FSH-R, LH-R, pentraxin 3, cyclooxygenase 2, hyaluronic acid synthase 2, the BMP antagonist-Gremlin, epidermal growth factor (EGF)-like signalling molecules amphiregulin, epiregulin and betacellulin, quantified by real-time PCR in cumulus cells cut from 1-2 cumulus oocyte complex/patient at the time of cumulus removal for ICSI. - Aneuploidy rates in the immature oocytes and unfertilized oocytes.;Timepoint(s) of evaluation of this end point: The samples for evaluation of secondary outcome measures will be obtained on the day of egg collection (about 14 weeks after they entered into the trial). The samples will be stored frozen until the assessment (molecular analysis and comparative genomic hybridization), which is planned to be performed in batches. | — |
Countries
United Kingdom
Contacts
Public ContactBruce Campbell
University of Nottingham
Outcome results
None listed