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出境医 / 临床实验 / Improving in Vitro Fertilization in Women With Poor Ovarian Response

Improving in Vitro Fertilization in Women With Poor Ovarian Response

Study Description
Brief Summary:
Improving the results of in vitro fertilization in women with poor ovarian response and early ovarian insufficiency

Condition or disease Intervention/treatment Phase
Poor Ovarian Response Ovarian Insufficiency Procedure: In Vitro Fertilization Not Applicable

Detailed Description:

BACKGROUND: Mechanical disruption of the Hippo signaling pathway in the ovaries can increase the likelihood of pregnancy and childbirth in women with early ovarian insufficiency. The method may also "work" in women with poor ovarian reserve and poor response to routine fertility treatments.

OBJECTIVE: To examine whether mechanical stimulation of ovaries by cutting the ovarian cortex treatment can increase eggs number aspirated during In Vitro Fertilization (IVF).

METHODS: Patients eligible for the study with poor ovarian response will receive treatment including laparoscopic surgery, resection, and transplantation of ovarian tissue in the same operation to improve the chances of IVF success and pregnancy. Participants will be assessed for surgical incisions and fertility assessment up to two weeks after treatment, including general physical examination, US pelvic examination, and blood tests for a hormonal profile to determine the initiation of ovarian stimulation and IVF. Patients will be monitored from 2 weeks to 1 year after treatment (once a week in the first two months and one month for one year after surgery), which will include a general physical examination, a pelvic ultrasound (US) and blood tests for the hormonal profile at the IVF clinic.

Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Improving the Results of in Vitro Fertilization in Women With Poor Ovarian Response and Early Ovarian Insufficiency
Actual Study Start Date : January 14, 2020
Estimated Primary Completion Date : July 31, 2021
Estimated Study Completion Date : July 31, 2022
Arms and Interventions
Arm Intervention/treatment
Experimental: Single ovary treatment Procedure: In Vitro Fertilization
Patients suitable for research with poor ovarian response will receive treatment including laparoscopic surgery, resection, and transplantation of ovarian tissue in the same operation to improve the chances of success of in vitro fertilization and pregnancy. Participants will be assessed for surgical incisions and fertility assessment up to two weeks after treatment, including general physical examination, US pelvic examination, and blood tests for a hormonal profile to determine the initiation of ovarian stimulation and IVF. Patients will be monitored from 2 weeks to 1 year after treatment (once a week in the first two months and one month for one year after surgery), which will include a general physical examination, a US test, and blood tests for the hormonal profile at the IVF clinic.
Experimental: Dual ovary treatment Procedure: In Vitro Fertilization
Patients suitable for research with poor ovarian response will receive treatment including laparoscopic surgery, resection, and transplantation of ovarian tissue in the same operation to improve the chances of success of in vitro fertilization and pregnancy. Participants will be assessed for surgical incisions and fertility assessment up to two weeks after treatment, including general physical examination, US pelvic examination, and blood tests for a hormonal profile to determine the initiation of ovarian stimulation and IVF. Patients will be monitored from 2 weeks to 1 year after treatment (once a week in the first two months and one month for one year after surgery), which will include a general physical examination, a US test, and blood tests for the hormonal profile at the IVF clinic.
Outcome Measures
Primary Outcome Measures :
  1. Number of oocytes [ Time Frame: up to 1 year ]
    Number of oocytes

  2. Fertilization rate [ Time Frame: up to 1 year ]
    Fertilization rate

  3. Embryos number [ Time Frame: up to 1 year ]
    Embryos number

  4. Pregnancies rate [ Time Frame: up to 1 year ]
    Pregnancies rate


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Volunteers with poor ovarian response to standard fertility treatments according to the criteria of the European Fertility Association (ESHRE).
  • Diagnosis of early ovarian insufficiency or symptoms that predict early ovarian insufficiency (imminent) seeking to become pregnant.

Exclusion Criteria:

Volunteers with

  • Severe endometriosis diagnosed with laparoscopy.
  • Previous major surgery involving ovaries.
  • Ovarian cancer.
  • Female reproductive malformations.
  • Contraindications for laparoscopic surgery.
Contacts and Locations

Locations
Layout table for location information
Israel
Barzilay University Medical Center Recruiting
Ashkelon, Israel
Contact: Shevach Friedler, Proffesor    972 8 6748882    shevachf@bmc.gov.il   
Contact: Yaniv Ovadia, Doctor    972 8 6745220    yanivo@bmc.gov.il   
Sponsors and Collaborators
Barzilai Medical Center
Tracking Information
First Submitted Date  ICMJE July 3, 2019
First Posted Date  ICMJE July 18, 2019
Last Update Posted Date May 7, 2020
Actual Study Start Date  ICMJE January 14, 2020
Estimated Primary Completion Date July 31, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 17, 2019)
  • Number of oocytes [ Time Frame: up to 1 year ]
    Number of oocytes
  • Fertilization rate [ Time Frame: up to 1 year ]
    Fertilization rate
  • Embryos number [ Time Frame: up to 1 year ]
    Embryos number
  • Pregnancies rate [ Time Frame: up to 1 year ]
    Pregnancies rate
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Improving in Vitro Fertilization in Women With Poor Ovarian Response
Official Title  ICMJE Improving the Results of in Vitro Fertilization in Women With Poor Ovarian Response and Early Ovarian Insufficiency
Brief Summary Improving the results of in vitro fertilization in women with poor ovarian response and early ovarian insufficiency
Detailed Description

BACKGROUND: Mechanical disruption of the Hippo signaling pathway in the ovaries can increase the likelihood of pregnancy and childbirth in women with early ovarian insufficiency. The method may also "work" in women with poor ovarian reserve and poor response to routine fertility treatments.

OBJECTIVE: To examine whether mechanical stimulation of ovaries by cutting the ovarian cortex treatment can increase eggs number aspirated during In Vitro Fertilization (IVF).

METHODS: Patients eligible for the study with poor ovarian response will receive treatment including laparoscopic surgery, resection, and transplantation of ovarian tissue in the same operation to improve the chances of IVF success and pregnancy. Participants will be assessed for surgical incisions and fertility assessment up to two weeks after treatment, including general physical examination, US pelvic examination, and blood tests for a hormonal profile to determine the initiation of ovarian stimulation and IVF. Patients will be monitored from 2 weeks to 1 year after treatment (once a week in the first two months and one month for one year after surgery), which will include a general physical examination, a pelvic ultrasound (US) and blood tests for the hormonal profile at the IVF clinic.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Poor Ovarian Response
  • Ovarian Insufficiency
Intervention  ICMJE Procedure: In Vitro Fertilization
Patients suitable for research with poor ovarian response will receive treatment including laparoscopic surgery, resection, and transplantation of ovarian tissue in the same operation to improve the chances of success of in vitro fertilization and pregnancy. Participants will be assessed for surgical incisions and fertility assessment up to two weeks after treatment, including general physical examination, US pelvic examination, and blood tests for a hormonal profile to determine the initiation of ovarian stimulation and IVF. Patients will be monitored from 2 weeks to 1 year after treatment (once a week in the first two months and one month for one year after surgery), which will include a general physical examination, a US test, and blood tests for the hormonal profile at the IVF clinic.
Study Arms  ICMJE
  • Experimental: Single ovary treatment
    Intervention: Procedure: In Vitro Fertilization
  • Experimental: Dual ovary treatment
    Intervention: Procedure: In Vitro Fertilization
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 17, 2019) 		40
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 31, 2022
Estimated Primary Completion Date July 31, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Volunteers with poor ovarian response to standard fertility treatments according to the criteria of the European Fertility Association (ESHRE).
  • Diagnosis of early ovarian insufficiency or symptoms that predict early ovarian insufficiency (imminent) seeking to become pregnant.

Exclusion Criteria:

Volunteers with

  • Severe endometriosis diagnosed with laparoscopy.
  • Previous major surgery involving ovaries.
  • Ovarian cancer.
  • Female reproductive malformations.
  • Contraindications for laparoscopic surgery.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Gender Based Eligibility: Yes
Ages  ICMJE 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Listed Location Countries  ICMJE Israel
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04024722
Other Study ID Numbers  ICMJE 0019-18-BRZ
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Shevach Friedler, Prof, Barzilai Medical Center
Study Sponsor  ICMJE Barzilai Medical Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Barzilai Medical Center
Verification Date May 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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