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A prospective, placebo-controlled, randomized study evaluating the influence of intracervical and intravaginal application of seminal plasma on the endometrial- and subendometrial vascularization and endometrial volume measured via 3-D power Doppler in an IVF/ICSI cycle.

A prospective, placebo-controlled, randomized study evaluating the influence of intracervical and intravaginal application of seminal plasma on the endometrial- and subendometrial vascularization and endometrial volume measured via 3-D power Doppler in an IVF/ICSI cycle.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
DRKS
Registry ID
DRKS00005364
Enrollment
100
Registered
2013-11-19
Start date
2011-01-01
Completion date
Unknown
Last updated
2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Z31.9

Interventions

Group 1: Using the semen sample achieved on the day of follicle aspiration SP was extracted by centrifugation and was stored in the incubator. Remaining to the SP a syringe was transferred to the cli

Sponsors

Landes Frauen und Kinderklinik Linz
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 41 Years

Inclusion criteria

Inclusion criteria: All woman were 18-41 years of age, nulliparous, non-smoker with a BMI under 35 and undergoing their first or second IVF/ICSI cycle at our clinic

Exclusion criteria

Exclusion criteria: Exclusion criteria including no embryo transfer due to ovarian hyperstimulation syndrome or fertilization failure, hepatitis B, hepatitis C, HIV, leucocytospermia and men with less than 0,5ml of SP. All patients with endometrial- such as polyps, or myometrial anomalies (fibroids) and congenital uterine abnormalities, or Ashermann- syndrome were excluded. Another exclusion criteria was required application of SP.

Design outcomes

Primary

MeasureTime frame
The following primary endpoints were defined: change of vascularization flow index (VFI) of the subendometrium between oocyte pick- up (baseline) and embryo transfer (1); change of vascularization index (VI) of the subendometrium between oocyte pick- up (baseline) and embryo transfer (2); change of flow index (FI) of the subendometrium between oocyte pick- up (baseline) and embryo transfer (3); change of vascularization flow index (VFI) of the endometrium between oocyte pick- up (baseline) and embryo transfer (4); change of vascularization index (VI) of the endometrium between oocyte pick- up (baseline) and embryo transfer (5); change of flow index (FI) of the endometrium between oocyte pick- up (baseline) and embryo transfer (6); change of endometrial volume between oocyte pick- up (baseline) and embryo transfer (7). Measurement was done 30 minutes prior to oocyte pick- up and 30 minutes prior to embryo transfer, using a GE Voluson I Ultrasound machine: GE Kretz, Austria. Volumetric and vascular measurements were then undertaken using Virtual Organ Computer- aided AnaLyses (VOCAL, GE Kretz).

Secondary

MeasureTime frame
Subendometrial Vaskularizations-Flow-Index at examination U2 (Embryo- or Blastocysttransfer), subendometrial Flow-Index U2, subendometrial Vaskularizationindex U2. Endometrial Vaskularization-Flow-Index U2, endometrial Flow-Index U2, endometrial Vaskularizationindex U2. Endometrium volume at examination U2. Measurement was done 30 minutes prior to oocyte pick- up and 30 minutes prior to embryo transfer, using a GE Voluson I Ultrasound machine: GE Kretz, Austria. Volumetric and vascular measurements were then undertaken using Virtual Organ Computer- aided AnaLyses (VOCAL, GE Kretz). Pregnancy rate was evaluated four weeks after embryo transfer (U3) (Final examination) via transvaginal ultrasound examination. Lifebirth- rate was evaluated using the austrian birthregister of in vitro fertilization.

Countries

Austria

Contacts

Public ContactRichard Mayer

Landes Frauen- und Kinderklinik Linz

richard.mayer@gespag.at+43505546323720

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026