To compare the cumulative ongoing pregnancy rate after transfer of frozen/thawed embryos in a cycle without ovarian hyperstimulation with transfer of fresh embryos in a cycle with ovarian hyperstimulation.
ID
Source
Brief title
Condition
- Sexual function and fertility disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Ongoing pregnancy defined by the presence of a viable intra-uterine pregnancy
at 12 weeks of gestation.
Secondary outcome
Secondary outcomes are embryo quality, implantation rate, biochemical
pregnancy, clinical pregnancy, multiple pregnancies, live birth, time to
pregnancy, health of babies born and costs.
Background summary
The chance of embryo implantation with IVF/ICSI is, unfortunately, still
disappointingly low. Only 25% of couples undergoing IVF/ICSI conceive. IVF/ICSI
cycles are characterized by ovarian hyperstimulation to obtain multiple oocytes
for in vitro fertilization. However, ovarian hyperstimulation does not only
cause more oocytes but also causes changes in the endometrium hampering
endometrial receptivity thereby creating suboptimal implantation chances. We
aim to improve the ongoing pregnancy rates in IVF/ICSI cycles by disengagement
of ovarian hyperstimulation and embryo transfer.
Study objective
To compare the cumulative ongoing pregnancy rate after transfer of
frozen/thawed embryos in a cycle without ovarian hyperstimulation with transfer
of fresh embryos in a cycle with ovarian hyperstimulation.
Study design
Randomised comparison of transfer of frozen/thawed embryos in cycles without
ovarian hyperstimulation (disengagement strategy) versus transfer of fresh
embryos in cycles with ovarian hyperstimulation (standard strategy).
Intervention
Ovarian hyperstimulation, oocyte retrieval and oocyte fertilization will be
performed using standard procedures. In the control arm one or two fresh
embryos will be transferred in the same cycle and supernumerary embryos of
sufficient quality will be cryopreserved and subsequentely transferred in a
cycle without ovarian hyperstimulation after thawing when pregnancy is not
achieved after fresh transfer. In the experimental arm, all embryos of
sufficient quality will be cryopreserved and transferred after thawing in
cycles without ovarian hyperstimulation .
Study burden and risks
The burden of participation equals the burden of a standard IVF/ICSI cycle,
i.e. a 3-week period with controlled ovarian hormonal stimulation, ultrasound
monitoring (4-5 times), endocrine monitoring (4-5 times) and transvaginal
follicle aspiration. The risks to the women are limited to the risks associated
with the IVF/ICSI procedure such as ovarian hyperstimulation syndrome and
infection. The benefit to the couple is the expected increased chance to
achieve a pregnancy.
Meibergdreef 9
Amsterdam 1105AZ
NL
Meibergdreef 9
Amsterdam 1105AZ
NL
Listed location countries
Age
Inclusion criteria
All couples that present to one of the participating centers for their first IVF/ICSI treatment.
Exclusion criteria
1.Women younger than 18 and older than 38year
2. Couples undergoing a PGD cycle.
3. Couples for which IVF/ICSI is used to prevent the transmission of HIV.
4. Couples undergoing a modified natural cycle.
5. Couples undergoing IVF/ICSI with surgically retrieved spermatozoa.
6. Women with borderline or invasive ovarian cancer.
7. Women with contraindications for IVF/ICSI treatment such as cardiovascular-pulmonary
disease, severe diabetes, bleeding disorders, immunodeficiency and morbid obesity
8. Women with premature ovarian failure.
9. Women with severe psychopathology, severe anxiety and inability to cope with treatment.
10. Not able or willing to provide informed consent.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL37056.000.11 |
| Other | NTR 3187(Dutch Trail Register) |
| OMON | NL-OMON24197 |