Diminished Ovarian Reserve Clinical Trial
Official title:
Follicular Flushing in Patients With Mono-follicular Growth
NCT number | NCT03831542 |
Other study ID # | 1 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | February 19, 2019 |
Est. completion date | May 6, 2019 |
Verified date | May 2019 |
Source | Centrum Clinic IVF Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Retrieval of an oocyte from a follicle relies on the release of the cumulus-oocyte-complex (COC) from the follicular wall into the lumen, thereby allowing aspiration by a needle. Flushing the follicle with multiple aspirations from the same follicle is used as a means to increase the ratio of COC per aspirated follicle. Data showed that follicular flushing is not superior to direct aspiration either in normally responding patients or in poor responders undergoing in vitro fertilization (IVF). There is no data in the literature regarding the issue in patients with mono-follicular growth. Direct aspiration or repeatedly flushing the follicle for those with a single follicle will be investigated.
Status | Completed |
Enrollment | 71 |
Est. completion date | May 6, 2019 |
Est. primary completion date | May 5, 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years to 40 Years |
Eligibility |
Inclusion Criteria: - women aged 18-40 years - primary infertility - diminished ovarian reserve with single mature follicle on the day of oocyte retrieval Exclusion Criteria: - natural cycle IVF - presence of endometriosis/endometrioma(s) - Absence of cumulus oocyte complex following oocyte retrieval - Severe male factor infertility - Pre-implantation genetic screening cycles |
Country | Name | City | State |
---|---|---|---|
Turkey | Centrum Clinic IVF Center | Ankara |
Lead Sponsor | Collaborator |
---|---|
Centrum Clinic IVF Center |
Turkey,
Haydardedeoglu B, Gjemalaj F, Aytac PC, Kilicdag EB. Direct aspiration versus follicular flushing in poor responders undergoing intracytoplasmic sperm injection: a randomised controlled trial. BJOG. 2017 Jul;124(8):1190-1196. doi: 10.1111/1471-0528.14629. — View Citation
von Horn K, Depenbusch M, Schultze-Mosgau A, Griesinger G. Randomized, open trial comparing a modified double-lumen needle follicular flushing system with a single-lumen aspiration needle in IVF patients with poor ovarian response. Hum Reprod. 2017 Apr 1;32(4):832-835. doi: 10.1093/humrep/dex019. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | mature oocyte | Confirmation of cumulus oocyte complex (COC) after microscopic examination of follicular fluid by a senior embryologist for each patient. | during oocyte retrieval procedure | |
Secondary | fertilization rate after micro-injection | Confirmation of pronuclei formation on the following day of microinjection by a senior embryologist in each patient. | 24 hours after microinjection procedure | |
Secondary | clinical pregnancy rate per embryo transfer | Confirmation of fetal cardiac activity on 5th or 6th week of gestation by a senior obstetrician in each pregnancy case. | untill 6 weeks |
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