NCT04118959

Brief Summary

ET is the final stage of IVF which independently influences the treatment outcome. Successful embryo implantation is dependent on uterine receptivity. Atosiban is a novel class of drug which is effective in priming the uterus for implantation. It reduces uterine contractions and increases endomyometrial perfusion, both of which have potential benefits regarding improved IRs, CPR, and ongoing pregnancy rates. Atosiban has a good embryonic safety profile. It has no systemic toxicity, no mutagenic effects, and no carcinogenic effects

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2019

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

October 6, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 8, 2019

Completed
2 days until next milestone

Study Start

First participant enrolled

October 10, 2019

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 20, 2021

Completed
5 days until next milestone

Study Completion

Last participant's last visit for all outcomes

November 25, 2021

Completed
Last Updated

September 28, 2021

Status Verified

September 1, 2021

Enrollment Period

2.1 years

First QC Date

October 6, 2019

Last Update Submit

September 27, 2021

Conditions

Recurrent Implantation Failure

Keywords

Recurrent implantation failureIVFAtosibanEmbryo Transfer

Outcome Measures

Primary Outcomes (2)

  • pregnancy rate

    B- HCG

    2 weeks

  • clinical pregnancy rate

    positive fetal heart beats

    4 weeks

Eligibility Criteria

Age22 Years - 40 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

those patients with a history of recurrent implantation failure

You may qualify if:

  • Women 22-40 years age
  • Body mass index- 18.5-30 kg/m 2
  • The normal uterine cavity on ultrasound scan
  • At least one good quality embryo present for transfer
  • Endometrium thickness ≥7.5 mm with endometrial volume 2-2.5 ml and good endometrial and subendometrial vascularity.

You may not qualify if:

  • \. Women ≥ 40 years age 2. Uterine abnormalities that can compromise the IRs (e.g., endometrial polyp, fibroids, hydrosalpinx, and adenomyosis) 3. Patients at risk of ovarian hyperstimulation syndrome 4. Patients with a history of hypersensitivity to atosiban 5. Endocrine dysfunction 6. Major organ dysfunction such as liver or kidney failure.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Al-BARAKA FERTILITY HOSPITAL

Adliya, Manama, 15006, Bahrain

RECRUITING

Central Study Contacts

Kamal eldin Rageh, M.D.

CONTACT

0097333153871dr_kamal_rageh@yahoo.com

Ahmed Barakat, FRCOG

CONTACT

0097317727888ahmed.barakat@yahoo.com

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
doctor , medical director

Study Record Dates

First Submitted

October 6, 2019

First Posted

October 8, 2019

Study Start

October 10, 2019

Primary Completion

November 20, 2021

Study Completion

November 25, 2021

Last Updated

September 28, 2021

Record last verified: 2021-09

Locations

BA(1)