The effect of rLH for controlled ovarian hyperstimulation in order to achieve an increase of 10% in top quality embryos.
ID
Source
Brief title
Condition
- Endocrine disorders of gonadal function
- Sexual function and fertility disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary outcome: Percentage of top-quality embryos
Secondary outcome
Secondary outcome
Number of follicles > 14 mm on hCG day
Number of retrieved oocytes
Number of metaphase II oocytes
Pronuclear morphology
Total number of embryos
Presence of early cleavage
Cleavage stage morphology
Number of embryos suitable for transfer
Biochemical, clinical, ongoing pregnancies
Live-birth rate
Background summary
LH is known to play a role in oocyte growth and maturation it may subsequently
play a relevant role in optimizing fertilization and embryo competence. On the
one hand we know that older women have less competent embryos, and on the other
hand we know that LH can have a beneficial effect on embryo-quality. We
therefore want to explore the beneficial effect of adding rLH to rFSH for
controlled ovarian hyperstimulation in IVF of ICSI, compared to rFSH alone.
Study objective
The effect of rLH for controlled ovarian hyperstimulation in order to achieve
an increase of 10% in top quality embryos.
Study design
Randomized, clinical study in 220 women from 35 years of age and women with IOF
undergoing IVF/ICSI
Intervention
Controlled Ovarian Hyperstimulation in a GnRH agonist long luteal protocol with
(1) 300 rFSH sc daily alone or
(2) 2:1 ratio rFSH : rLH i.e. 300 IU/L rFSH and 150 IU/L rLH sc
Followed by a standard IVF or ICSI procedure.
The obtained embryo's will be classified on morfology by a computer program
called Fertimorf.
Study burden and risks
No risk, other then the risk an IVF/ICSI procedure entails.
Meibergdreef 9
1105 AZ
NL
Meibergdreef 9
1105 AZ
NL
Listed location countries
Age
Inclusion criteria
Women are eligible if the following apply:
1. Patients between 35 and 43 years of age
2. Patients with IOF, <35 years
3. Valid indication for IVF or ICSI
4. Undergoing IVF/ICSI first oocyte retrieval
Exclusion criteria
A woman must not be entered if any of the following apply:
1. Endocrinopathological disease as: Cushing*s syndrome, adrenal hyperplasia, hyperprolactinaemia, acromegaly, hypothalamic amenorrhea, hypothyroidy, diabetes mellitus type I, PCOS
2. If not willing or able to sign the informed consent form
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2007-007487-22-NL |
| CCMO | NL20406.018.08 |