- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT02683967
The Impact of Acupuncture on the Success Rates of IVF (In Vitro Fertilisation) Treatments
The Impact of Acupuncture on the Success Rate of IVF Treatments
Studieöversikt
Detaljerad beskrivning
Failing to conceive naturally poses significant stress to the infertile couple. It creates a feeling of failure and frustration. It has been found that the use of complementary therapies makes women feel empowered, with a sense of regaining control of the body.
The popularity of acupuncture is increasing. A significant proportion of couples having fertility treatment, especially IVF (In-Vitro Fertilisation) ask their clinician about using acupuncture and some patients undergo acupuncture privately without reporting to their clinicians.
The effectiveness of acupuncture on IVF has been extensively researched; however the results are varied and not conclusive. This is due to previous studies varying significantly in their study design, acupuncture timing and the final outcome measure. As a result of the difference in the studies it is not clear whether acupuncture is beneficial regarding IVF success rates and whether it should be offered to women undergoing IVF.
Studietyp
Inskrivning (Faktisk)
Fas
- Inte tillämpbar
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
Inclusion Criteria:
- Women under the age of 43 years with a BMI of less than 30 undergoing 1st or no more than their 2nd failed fresh IVF or ICSI cycle.
Exclusion Criteria:
- Those women undergoing frozen embryo replacement cycle or receiving donor eggs, BMI > 30 or currently having acupuncture/ any other form of CAM, having contraindication to acupuncture like those with HIV, Hep C will be excluded.
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Faktoriell uppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
---|---|
Aktiv komparator: Acupuncture
These patients received acupuncture during the follicular development phase and on the day of egg collection.
|
patients received a Delphi acupuncture at least 3 times during their fertility treatment cycle.
|
Inget ingripande: Control
Patients received standard care, no acupuncture.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Live birth rate
Tidsram: 18 months
|
The primary objective is to determine the clinical effectiveness of acupuncture in improving live birth rates in women undergoing IVF
|
18 months
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Clinical pregnancy rate
Tidsram: 18 months
|
The secondary objective is to determine whether acupuncture improves clinical pregnancy rate
|
18 months
|
Multiple pregnancy
Tidsram: 9 months
|
To determine whether there is an increased rate of multiple pregnancy
|
9 months
|
Quality of life
Tidsram: 9 months
|
To examine the effect of acupuncture on improving the quality of life for women by means of EQ% quality of life questionnaires
|
9 months
|
Samarbetspartners och utredare
Utredare
- Huvudutredare: Karin Gillerman, NHS Honorary Contract
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- FE1303
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
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