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A single-center non-blinded randomized controlled trial on the effect of ovarian hyperstimulation on endometrial receptivity.


- candidate number10662
- NTR NumberNTR3187
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR9-dec-2011
- Secondary IDsNL 37056.000.11 CCMO
- Public TitleA single-center non-blinded randomized controlled trial on the effect of ovarian hyperstimulation on endometrial receptivity.
- Scientific TitleA single-center non-blinded randomized controlled trial on the effect of ovarian hyperstimulation on endometrial receptivity
- ACRONYMENDO-RECEPT
- hypothesisTo investigate whether disengagement of embryo transfer from ovarian hyperstimulation leads to higher ongoing pregnancy rates.
- Healt Condition(s) or Problem(s) studiedSubfertility, Infertility
- Inclusion criteriaSubfertile couples with female age <43 undergoing IVF (in vitro fertilization) or ICSI (intracytoplasmatic sperm injection).
- Exclusion criteria1. Couples undergoing a PGD cycle;
2. Couples for which IVF/ICSI is used to prevent the transmission of HIV;
3. Couples undergoing a modified natural cycle;
5. Women with borderline or invasive ovarian cancer;
6. Women with contraindications for IVF/ICSI treatment such as cardiovascular-pulmonary disease, severe diabetes, bleeding disorders, immunodeficiency and morbid obesity;
7. Women with premature ovarian failure;
8. Women with severe psychopathology, severe anxiety and inability to cope with treatment;
9. Not able or willing to provide informed consent.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-jan-2013
- planned closingdate1-mei-2015
- Target number of participants193
- InterventionsOvarian hyperstimulation, oocyte retrieval and oocyte fertilization will be performed using standard procedures.
In the control arm, one or two fresh embryo(s) will be transferred in the same cycle with cryopreservation of all supernumerary embryos and subsequent transfer of frozen/thawed embryos in artificial cycles if pregnancy is not achieved after fresh transfer.
In the experimental arm, all embryos will be cryopreserved for subsequent transfer in artificial cycles.
- Primary outcomePrimary outcome measure will be cumulative ongoing pregnancy rate per cycle after twelve months of treatment.
- Secondary outcomeSecondary outcome measures will be embryo quality, clinical pregnancy rate, miscarriage rate, live birth rate, time to pregnancy, birth weight and percentage of children with congenital abnormalities.
- TimepointsThe duration of the study is 2.25 years.
- Trial web siteN/A
- statusplanned
- CONTACT FOR PUBLIC QUERIESMD. K.M. Wong
- CONTACT for SCIENTIFIC QUERIESDr. Sebastiaan Mastenbroek
- Sponsor/Initiator ZonMw: The Netherlands Organization for Health Research and Development
- Funding
(Source(s) of Monetary or Material Support)
ZON-MW, The Netherlands Organization for Health Research and Development
- PublicationsN/A
- Brief summaryOvarian hyperstimulation is used in IVF/ICSI cycles to retrieve multiple oocytes. The downside of ovarian hyperstimulation is that it negatively impacts endometrial receptivity. The ENDO-RECEPT study investigates whether disengagement of embryo transfer from ovarian hyperstimulation leads to an improved ongoing pregnancy rate as compared to the standard treatment of fresh embryo transfer in a stimulated cycle.
- Main changes (audit trail)17-jun-2014: Notification about removal of exclusion criterium 4: "Couples undergoing IVF/ICSI with surgically retrieved spermatozoa (MESA or TESE)" from the start of the study - AB
- RECORD9-dec-2011 - 22-jun-2014


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