NCT04081870

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2014

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2014

Completed
5.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2019

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

September 5, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 9, 2019

Completed
Last Updated

September 11, 2019

Status Verified

September 1, 2019

Enrollment Period

5.2 years

First QC Date

September 5, 2019

Last Update Submit

September 9, 2019

Conditions

Keywords

doppler,endometrial,implantation

Outcome Measures

Primary Outcomes (3)

  • chemical pregnancy

    positive pregnancy test

    14 day

  • the clinical pregnancy

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

    28 day

  • The ongoing pregnancy

    was detected by abdominal ultrasound at 12 weeks.

    3 months

Study Arms (1)

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

Interventions

3D power doppler USDIAGNOSTIC_TEST

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.

ICSI cases

Eligibility Criteria

Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

infertile women in need for ICSI due to male factor

You may qualify if:

  • age; 22-35 years,
  • BMI; less than 35 kg/m2,
  • Husband with oligo- or oligoasthenospermia.

You may not qualify if:

  • \\1-gross uterine and tubal pathology,
  • Development of OHSS,
  • poor responders,
  • failure of oocyte fertilization or failure of the embryos to reach the blastocyst stage and
  • Refusal to participate in the study at any step of the ICSI cycle.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Ledee-Bataille N, Lapree-Delage G, Taupin JL, Dubanchet S, Frydman R, Chaouat G. Concentration of leukaemia inhibitory factor (LIF) in uterine flushing fluid is highly predictive of embryo implantation. Hum Reprod. 2002 Jan;17(1):213-8. doi: 10.1093/humrep/17.1.213.

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Study Officials

  • khalid salama

    Benha University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

September 5, 2019

First Posted

September 9, 2019

Study Start

February 1, 2014

Primary Completion

April 1, 2019

Study Completion

May 1, 2019

Last Updated

September 11, 2019

Record last verified: 2019-09