Role of Atosiban in Recurrent Implantation Failure (RIF)

The Value of Atosiban on the Day of Embryo Transfer in Patients With Recurrent Implantation Failure

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

Study Overview

• Status: Recruiting
• Conditions: 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.

• Study Type: Observational
• Enrollment (Anticipated): 150

Contacts and Locations

• Study Contact: Name: Kamal eldin Rageh, M.D.; Phone Number: 0097333153871; Email: dr_kamal_rageh@yahoo.com
• Study Contact Backup: Name: Ahmed Barakat, FRCOG; Phone Number: 0097317727888; Email: ahmed.barakat@yahoo.com

Study Locations

• Bahrain
  • Manama
    • Adliya, Manama, Bahrain, 15006
      • Recruiting
      • Al-BARAKA FERTILITY HOSPITAL
      • Contact: AHMED BARAKAT, FRCOG; Phone Number: 0097336660500; Email: ahmed_barakat@yahoo.com
      • Contact: Kamal Rageh, M.D; Phone Number: 0097333153871; Email: dr_kamal_rageh@yahoo.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 38 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

those patients with a history of recurrent implantation failure

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
pregnancy rate	B- HCG	2 weeks
clinical pregnancy rate	positive fetal heart beats	4 weeks

Collaborators and Investigators

• Sponsor: Al Baraka Fertility Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 10, 2019
• Primary Completion (Anticipated): November 20, 2021
• Study Completion (Anticipated): November 25, 2021

Study Registration Dates

• First Submitted: October 6, 2019
• First Submitted That Met QC Criteria: October 6, 2019
• First Posted (Actual): October 8, 2019

Study Record Updates

• Last Update Posted (Actual): September 28, 2021
• Last Update Submitted That Met QC Criteria: September 27, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Keywords: IVF; Recurrent implantation failure; Embryo Transfer; Atosiban
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Recurrence
• Other Study ID Numbers: K.Rageh

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No