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Role of Atosiban in Recurrent Implantation Failure (RIF)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04118959
Recruitment Status : Recruiting
First Posted : October 8, 2019
Last Update Posted : November 20, 2019
Sponsor:
Information provided by (Responsible Party):
Dr. Kamal Rageh, Al Baraka Fertility Hospital

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

Condition or disease
Recurrent Implantation Failure

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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Study Type : Observational
Estimated Enrollment : 150 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: The Value of Atosiban on the Day of Embryo Transfer in Patients With Recurrent Implantation Failure
Actual Study Start Date : October 10, 2019
Estimated Primary Completion Date : December 15, 2019
Estimated Study Completion Date : December 15, 2019

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. pregnancy rate [ Time Frame: 2 weeks ]
    B- HCG

  2. clinical pregnancy rate [ Time Frame: 4 weeks ]
    positive fetal heart beats



Information from the National Library of Medicine

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Ages Eligible for Study:   22 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
those patients with a history of recurrent implantation failure
Criteria

Inclusion Criteria:

  1. Women 22-40 years age
  2. Body mass index- 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:

  • 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 hypersensitivity to atosiban 5. Endocrine dysfunction 6. Major organ dysfunction such as liver or kidney failure.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04118959


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

Locations
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Bahrain
Al-BARAKA FERTILITY HOSPITAL Recruiting
Adliya, Manama, Bahrain, 15006
Contact: AHMED BARAKAT, FRCOG    0097336660500    ahmed_barakat@yahoo.com   
Contact: Kamal Rageh, M.D    0097333153871    dr_kamal_rageh@yahoo.com   
Sponsors and Collaborators
Al Baraka Fertility Hospital

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Responsible Party: Dr. Kamal Rageh, doctor , medical director, Al Baraka Fertility Hospital
ClinicalTrials.gov Identifier: NCT04118959    
Other Study ID Numbers: K.Rageh
First Posted: October 8, 2019    Key Record Dates
Last Update Posted: November 20, 2019
Last Verified: November 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dr. Kamal Rageh, Al Baraka Fertility Hospital:
Recurrent implantation failure
IVF
Atosiban
Embryo Transfer
Additional relevant MeSH terms:
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Atosiban
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Tocolytic Agents
Reproductive Control Agents