Does dehydroepiandrosterone (DHEA) improve IVF outcomes in poor responders?
| ISRCTN | ISRCTN78447218 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN78447218 |
| EudraCT/CTIS number | 2013-001661-16 |
| Secondary identifying numbers | FE 1202 |
- Submission date
- 26/04/2013
- Registration date
- 29/10/2013
- Last edited
- 01/02/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Pregnancy and Childbirth
Plain English Summary
Background and study aims
One in seven couples have difficulty conceiving despite regular unprotected sexual intercourse. Some of these couples will end up having medical assistance to get pregnant, often in the form of in-vitro fertilisation (IVF/test-tube babies). This will include couples with or without medical problems making natural conception difficult or impossible and those who cannot fall pregnant naturally e.g. same sex couples. The aim of IVF is to assist women to produce many eggs, remove the eggs surgically and fertilise them outside the body using her husband's or donor sperm; transferring one or more of the resulting embryos (fertilised eggs) to her womb to develop as a baby. One of the factors that determine the success of IVF is how many eggs are produced, as this will determine how many embryos are created and allow the best embryos to be selected for transfer to the womb. Some women tend either not to respond to the drugs that cause egg production during IVF or produce very few eggs and are termed poor responders. Often their IVF treatment is either unsuccessful or stopped and it can be very distressing for all involved. Dehydroepiandrosterone (DHEA) is a naturally occurring hormone that is thought to increase the number of eggs produced by these women when given before and during their IVF treatment. There has been no properly conducted research to test whether this is actually true and that is what we propose to do. We aim to study whether pregnancy rates are improved after IVF in poor responders when given DHEA. We will also look at the number of eggs the produce, the quality of their embryos as well as how many of their pregnancies result in a live birth or miscarriage.
Who can participate?
Women who meet an internationally agreed consensus definition of poor responders having IVF at our centre who agree to take part in the study. The women will have any two of the following:
1. Advanced maternal age (≥40 years) or any other risk factor for poor ovarian response (POR)
2. Previous poor ovarian response
3. An abnormal ovarian reserve test
What does the study involve?
Two groups of poor responders going through IVF (200 in each group) will be studied. One group will be given 75 mg DHEA daily and the other a placebo (dummy tablet) to take for 10 weeks before their IVF. Patients will be assigned to the groups at random and neither they nor the researchers will know which medication they are taking. There will be no change to their IVF treatment. We will follow their treatment and compare the number of women in each group who get pregnant.
What are the possible benefits and risks of participating?
The main benefit of the study is to provide a definitive answer whether DHEA make a difference in IVF outcome in this group of women. If the claims about the effects of DHEA are true, then those in the group taking it, and in the broader context many poor responder women, will benefit by getting pregnant. If the claims are not proven then again many poor responder women will be spared the financial and emotional cost of using an ineffective drug. As far as we can tell from our reading, DHEA is safe at the dose and duration that we will be using it. Several women have used it with no reported significant risk.
Where is the study run from?
1. Homerton Fertility Centre London (UK)
2. The Leeds Centre for Reproductive Medicine (UK)
3. Oxford Fertility, Institute of Reproductive Sciences (UK)
4. Hewitt Fertility Centre at Liverpool Women’s NHS Foundation Trust (UK)
5. Glasgow Royal Infirmary (UK)
6. Complete Fertility Southampton (UK)
When is the study starting and how long is it expected to run for?
The study is expected to start recruiting in August 2017 for two years. The trial will end one year after the last baby is delivered.
Who is funding the study?
Homerton University Hospital NHS Foundation Trust (UK)
Who is the main contact?
Professor Roy Homburg
r.homburg@gmail.com
Contact information
Scientific
Homerton Fertility Centre
Homerton Row
London
E9 6SR
United Kingdom
Study information
| Study design | Randomised double-blind placebo-controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | Does dehydroepiandrosterone (DHEA) improve IVF outcomes in poor responders? A randomised, double-blind, placebo-controlled trial |
| Study hypothesis | A randomised, double-blind, placebo-controlled trial of 400 poor responders (200 in each arm) to assess the effect of 75 mg DHEA given for 10 weeks prior to ovarian stimulation on clinical pregnancy rate, oocyte retrieval, embryo numbers and quality, miscarriage rates and live birth rate after IVF. |
| Ethics approval(s) | Approved 04/10/2016 |
| Condition | Infertility |
| Intervention | Controlled ovarian hyperstimulation and in-vitro fertilisation. Two groups of poor responders going through IVF (200 in each group). Intervention: 75 mg DHEA daily Control: placebo to take for 10 weeks before their IVF |
| Intervention type | Other |
| Primary outcome measure | Clinical pregnancy rates (ultrasound confirmation of a foetus with a heartbeat at 6-8 weeks gestation) |
| Secondary outcome measures | 1. Ovarian reserve defined AMH levels before and after ten weeks of DHEA supplementation 2. Number of eggs retrieved 3. Number and quality (grade) of embryos available for transfer/freezing 4. Ongoing pregnancies after 14 weeks gestation (miscarriage rates) |
| Overall study start date | 03/06/2013 |
| Overall study end date | 31/12/2020 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target number of participants | 400 patients (200 in each arm) |
| Participant inclusion criteria | Current inclusion criteria as of 24/10/2017: Inclusion criteria are based on the ESHRE definition of poor responders and would include any patient with any two of the following: 1. Age ≥ 40 years 2. Markers for poor ovarian reserve (AMH <7 pmol/L(<1.1 ng/ml) and/or AFC< 7) 3. Previous poor response to ovarian stimulation ( ≤3 oocytes with a conventional stimulation protocol) Previous inclusion criteria: European Society of Human Reproduction and Embryology (ESHRE) criteria for poor responders: 1. Age > 40 years 2. Markers for poor ovarian reserve [Anti-Mullerian Hormone (AMH) < 0.5 ng/ml (5 pmol/L), Follicle-Stimulating Hormone (FSH) > 15 IU, Antral Follicle Counts (AFC) < 6] 3. Previous poor response to ovarian stimulation (less than three mature follicles on day of hCG trigger/cycle cancellation due to poor response/less than three oocytes retrieved) |
| Participant exclusion criteria | Current exclusion criteria as of 24/10/2017: 1. Women ˃42 years 2. Women with premature ovarian failure/premature menopause (FSH>40 U/L) 3. Women already taking DHEA. 4. Patients with a known allergy to the trial drug or any of the active ingredients in the placebo Previous exclusion criteria: 1. Women > 42 years 2. Women with premature ovarian failure/premature menopause (FSH > 40 U/L) |
| Recruitment start date | 25/08/2017 |
| Recruitment end date | 25/08/2019 |
Locations
Countries of recruitment
- England
- Scotland
- United Kingdom
Study participating centres
E9 6SR
United Kingdom
LS14 6UH
United Kingdom
OX4 2HW
United Kingdom
L8 7SS
United Kingdom
G4 0SF
United Kingdom
SO16 5YA
United Kingdom
Sponsor information
Hospital/treatment centre
R&D Department
Homerton Row
London
E9 6SR
England
United Kingdom
"ROR" |
https://ror.org/01zpp3d44 |
|---|
Funders
Funder type
Hospital/treatment centre
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Will be provided in scientific journal and presented at meetings. |
| IPD sharing plan | Not provided at time of registration |
Editorial Notes
01/02/2022: Internal review.
04/12/2017: The overall trail end date has been updated from 29/05/2015 to 31/12/2020. The recruitment dates have been updated from 03/06/2013-03/06/2014 to 25/08/2017-25/08/2019.
24/10/2017: The target number of participants was changed from 150 patients (75 in each arm) to 400 patients (200 in each arm).
