IS Three d Power Doppler of the Endometrial and Subendometrial Regions Effective in Predicting Endometrial Implantation?

Sponsor
Benha University (Other)
Overall Status
Completed
CT.gov ID
NCT04081870
Collaborator
(none)
120
62.9

Study Details

Study Description

Brief Summary

Three D power Doppler US was done for every woman at the day after HCG administration. Ovum pick up was done after 35 hours following HCG administration. The luteal phase was supported by progesterone 300 mg per day (progest, micronized progesterone 100mg, Technopharma, Egypt, for pharco pharmaceuticals, Amriya- Alexandria). Five days following ovum pick up, the embryos were transferred at the blastocyst stage.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: 3D power doppler US

Detailed Description

All women underwent long agonist protocol for controlled ovarian hyperstimulation described by Chang et al. (14) The GnRH agonist was started in the previous mid-luteal phase (decapeptylR R 0.1mg, Triptorelin-Acetate, Ferring GmbH, Wittland 11, D-24109, and Kiel, Germany). After the confirmation of pituitary down regulation (serum LH less than 5 m IU/ml and serum E2 less than 50 pg /ml), the HMG ampoules were started by 225 IU/day (Gonapure 75 IU, IBSA Institute Biochimique SA, Switzerland). During the follow up of overstimulation, the doses were adjusted according to the response of patient. All women underwent serial TVS until at least three dominant follicles were reached in every woman. When the dominant follicles reached 18-20 mm, HCG 10000 (Choriomon 5000 IU, IBSA Institute Biochimique SA, Switzerland) was administered. Three D power Doppler US was done for every woman at the day after HCG administration. Ovum pick up was done after 35 hours following HCG administration. The luteal phase was supported by progesterone 300 mg per day (progest, micronized progesterone 100mg, Technopharma, Egypt, for pharco pharmaceuticals, Amriya- Alexandria). Five days following ovum pick up, the embryos were transferred at the blastocyst stage. Twelve days later to embryo transfer, serum pregnancy test was done and if positive (chemical pregnancy), the clinical pregnancy was confirmed by TVS for detection of gestational sacs and embryo cardiac activity. The ongoing pregnancy was detected by abdominal ultrasound at 12 weeks.

Study Design

Study Type:
Observational
Actual Enrollment :
120 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
IS Three d Power Doppler of the Endometrial and Subendometrial Regions Effective?
Actual Study Start Date :
Feb 1, 2014
Actual Primary Completion Date :
Apr 1, 2019
Actual Study Completion Date :
May 1, 2019

Arms and Interventions

Arm Intervention/Treatment
ICSI cases

All women underwent long agonist protocol for controlled ovarian hyperstimulation The GnRH agonist was started in the previous mid-luteal phase . After the confirmation of pituitary down regulation , the HMG ampoules were started by 225 IU/day . During the follow up of overstimulation, the doses were adjusted according to the response of patient. All women underwent serial TVS until at least three dominant follicles were reached in every woman. When the dominant follicles reached 18-20 mm, HCG 10000 was administered. Three D power Doppler US was done for every woman at the day after HCG administration. Ovum pick up was done after 35 hours following HCG administration. The luteal phase was supported by progesterone 300 mg per day . Five days following ovum pick up, the embryos were transferred at the blastocyst stage.

Diagnostic Test: 3D power doppler US
Three D power Doppler US was done for every woman at the day after HCG administration. Ovum pick up was done after 35 hours following HCG administration.

Outcome Measures

Primary Outcome Measures

  1. chemical pregnancy [14 day]

    positive pregnancy test

  2. the clinical pregnancy [28 day]

    was confirmed by TVS for detection of gestational sacs and embryo cardiac activity.

  3. The ongoing pregnancy [3 months]

    was detected by abdominal ultrasound at 12 weeks.

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
Inclusion Criteria:

a

  • age; 22-35 years,

  • BMI; less than 35 kg/m2,

  • Husband with oligo- or oligoasthenospermia.

Exclusion Criteria:
  • \1-gross uterine and tubal pathology,

  • 2-Development of OHSS,

  • 3-poor responders,

  • 4-failure of oocyte fertilization or failure of the embryos to reach the blastocyst stage and

  • 5-Refusal to participate in the study at any step of the ICSI cycle.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Benha University

Investigators

  • Principal Investigator: khalid salama, Benha University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
khalid mohammed salama, principal investigator, Benha University
ClinicalTrials.gov Identifier:
NCT04081870
Other Study ID Numbers:
  • khalid 6
First Posted:
Sep 9, 2019
Last Update Posted:
Sep 11, 2019
Last Verified:
Sep 1, 2019
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by khalid mohammed salama, principal investigator, Benha University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 11, 2019