ClinicalTrials.gg
Status unknownNCT04118959RIFUpdated Sep 28, 2021

Role of Atosiban in Recurrent Implantation Failure

An observational study in Recurrent Implantation Failure, sponsored by Al Baraka Fertility Hospital. Status unknown at 1 site in Bahrain. Open to female participants aged 22 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-09-28.

Sponsored by Al Baraka Fertility Hospital · Observational

The sponsor has not verified this record recently (last verified Sep 2021), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
150
Ages
22 Years to 40 Years
Sex
Female
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Study 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

Read the detailed description

ET is a critical step of an IVF cycle that merits the utmost attention. Its success depends on the frequency of uterine contractions, the endometrial receptivity and the quality of embryos transferred.

Uterine contractions are the most fundamental constituents of the uterine receptivity. Excessive contractions may decrease the implantation potential of embryos by expelling the embryos from the uterus. Studies have revealed a six-fold increase in uterine contractility in IVF cycles when measured before ET as compared to the condition before ovulation in natural cycles. Excessive manipulation of the cervix such as the use of tenaculum during difficult ET can also trigger uterine contractions, consequently leading to failure of embryo implantation.

IVF success rates have been potentially improved by the use of drugs that inhibit pronounced uterine contractions at the time of ET. Treatment strategies such as the use of beta-agonists or nonsteroidal anti-inflammatory agents for tocolysis have not been beneficial in IVF-ET procedures.

Atosiban is a combined oxytocin/vasopressin V1A antagonist. It functions mainly by blocking oxytocin and vasopressin V1a receptors to decrease the frequency and amplitude of uterine contractions, which enhances implantation and pregnancy rates. RIF remains unexplained in most cases, which results in considerable variation in how RIF is treated and managed. Atosiban competes with oxytocin at oxytocin receptors in endometrial cells and inhibits oxytocin-induced PGF2α release, thus inhibiting uterine contractions and increasing chances of embryo implantation and may add value in improving the outcome in RIF patients.

Recently published studies showed that atosiban inhibits oxytocin-induced PGF2α and uterine contractility, consequently leading to improved IRs. Studies have shown a considerable reduction in the frequency of uterine contractions before and after the administration of atosiban in women undergoing ET.

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Conditions studied

  • Recurrent Implantation Failure

Keywords

  • Recurrent implantation failure
  • IVF
  • Atosiban
  • Embryo Transfer
03

In context

Lead sponsor

Al Baraka Fertility Hospital is the lead sponsor of 8 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
22 Years to 40 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

those patients with a history of recurrent implantation failure

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

    1. 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 to atosiban 5. Endocrine dysfunction 6. Major organ dysfunction such as liver or kidney failure.
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
150 participants (estimated)
Patient registry
No
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What researchers measure

Primary outcomes

  1. pregnancy rate

    B- HCG

    Time frame: 2 weeks

  2. clinical pregnancy rate

    positive fetal heart beats

    Time frame: 4 weeks

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Study locations

1 of 1 sites recruiting
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 28, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04118959
Lead sponsor
Al Baraka Fertility Hospital
Responsible party
Dr. Kamal Rageh (doctor , medical director, Al Baraka Fertility Hospital) — Principal investigator
First posted
Oct 8, 2019
Start date
Oct 10, 2019
Primary completion
Nov 20, 2021 (estimated)
Completion
Nov 25, 2021 (estimated)
Last update
Sep 28, 2021

Study contacts

Kamal eldin Rageh, M.D.
Contact
dr_kamal_rageh@yahoo.com
0097333153871
Ahmed Barakat, FRCOG
Contact
ahmed.barakat@yahoo.com
0097317727888

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Sep 2021. You cannot join it, but the record below documents what was studied.

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