No registrations found.
ID
Source
Brief title
Health condition
Subfertility or infertility
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary outcome measure will be cumulative ongoing pregnancy rate per cycle after twelve months of treatment.
Secondary outcome
Secondary 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.
Background summary
Ovarian 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.
Study objective
To investigate whether disengagement of embryo transfer from ovarian hyperstimulation leads to higher ongoing pregnancy rates.
Study design
The duration of the study is 2.25 years.
Intervention
Ovarian 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.
Femke Mol
Amsterdam 1105 AZ
The Netherlands
+31 (0)20 556 63557
f.mol@amsterdamumc.nl
Femke Mol
Amsterdam 1105 AZ
The Netherlands
+31 (0)20 556 63557
f.mol@amsterdamumc.nl
Inclusion criteria
Subfertile couples with female age <43 undergoing IVF (in vitro fertilization) or ICSI (intracytoplasmatic sperm injection).
Exclusion criteria
1. 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.
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL3039 |
| NTR-old | NTR3187 |
| CCMO | NL37056.000.11 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |
| OMON | NL-OMON38364 |