Women With Poor Ovarian Response Clinical Trial
Official title:
GnRH Agonist Triggering Supplemented With Hcg in Women With Poor Ovarian
| Verified date | April 2014 |
| Source | Sheba Medical Center |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Israel: Ministry of Health |
| Study type | Interventional |
During the last decades, owing to the growing tendency of women to delay childbearing plans
because of career and personal priorities, fertility specialists today are seeing more and
more women with poor ovarian reserve and with poor ovarian response Controlled ovarian
hyperstimulation (COH) is considered a important factor in the success of in vitro
fertilization-embryo transfer (IVF-ET), enabling the recruitment of multiple oocytes and,
thereby, resulting in more than one embryo. However, owing to the extreme variability in
ovarian response to COH, in a subgroup of patients with poor ovarian response, this method
may yield a very small number of follicles After succeeding in maximal recruitment of the
follicles, the triggering of ovulation is extremely important in order to achieve, as many
as, mature oocytes.
Several studies have reported retrieval of more mature oocytes after GnRH agonist triggering
compared to the number of oocytes retrieved after hCG. Among the possible advantages of GnRH
agonist for final oocyte maturation is the simultaneous induction of an FSH surge. The role
of the natural mid-cycle FSH surge is not fully clear. FSH was reported to induce LH
receptor formation in luteinizing granulosa cells, and to promote oocyte nuclear maturation
and cumulus expansion .
Another method described to trigger ovulation is the "Dual triggering"- GnRH agonist 40 h
prior to ovum pickup and hCG added 6 h after the first trigger. The dual triggering was
described as the treatment in cases with recurrent empty follicles.
The aim of the present study is to evaluate three different methods of ovulation triggering
in women with poor ovarian response
| Status | Recruiting |
| Enrollment | 60 |
| Est. completion date | July 2015 |
| Est. primary completion date | July 2015 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Female |
| Age group | 18 Years to 45 Years |
| Eligibility |
Inclusion Criteria: - Women with low ovarian response according to the Bologna criteria, undergoing IVF treatments for this cause. Exclusion Criteria: - Women with good ovarian response. - Women with low ovarian response who are carriers of fragile X |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Israel | Sheba medical center | Ramat Gan |
| Lead Sponsor | Collaborator |
|---|---|
| Sheba Medical Center |
Israel,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | The main outcome is the number of mature oocytes | up to 12 months | No | |
| Primary | number of embryos appropriate for transfer | up to 12 month | No | |
| Secondary | pregnancy rate | up to 12 months | No |