Evaluation of Pregnancy Outcome with Usage of Drug-free In-vitro Activation of Follicles Ovary

NCT06769789 | Not Yet Recruiting

• 1 other identifier: IR.MUMS.IRH.REC.1403.127
• Study Type: interventional
• Target: 23
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study is the pilot study to evaluate the effect of Drug-free in vitro activation to improve the outcomes of IVF in poor responder women

Conditions

Infertility (IVF Patients); Infertile Females or Females with Ovarian Insufficiency

Outcome Measures

Primary Outcomes (3)

• The number of oocytes obtained at oocyte pick-up (OPU)

  Within 3 weeks after ovarian stimulation

• Number of embryos

  Within 3 weeks after ovarian stimulation

• Quality of embryos at the end of IVF treatment

  A grade embryo was defined to have four blastomeres on the second day and seven or eight blastomeres on the third day with equal size and \<20% fragmentation (high quality). Blastocyst embryos were assessed according to Gardner's criteria.

  Within 3 weeks after ovarian stimulation

Secondary Outcomes (3)

• Implantation rate

  4-8 weeks after transfer

• Clinical pregnancy rate

  one month after transfer

• Miscarriage rate

  20 weeks after transfer

Study Arms (1)

Experimental: Drug -free invitro activation of ovary in women

EXPERIMENTAL

Other: Drug free invitro activation Ovary

Interventions

Drug free invitro activation Ovary OTHER

Drug free invitro activation Ovary

Experimental: Drug -free invitro activation of ovary in women

Eligibility Criteria

• Age: 21 Years - 35 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Women under 35 years of age who have one of the following characteristics:
• Or poor response to gonadotropins in a previous IVF cycle (fewer than 3 oocytes in a previous IVF cycle)
• Or ovarian reserve test AMH less than 1.1

You may not qualify if:

• Unwillingness to continue working with the researcher during the procedure

Sponsors & Collaborators

• Malihe Mahmoudinia: lead

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Central Study Contacts

Malihe Mahmoudinia

CONTACT

_+98513338801; Mahmoudiniam@mums.ac.ir

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor of obstetrics & Gynecology, Fellowship of infertility, Faculty of Medicine, Mashhad University of Medical Sciences, Mashhad, Iran

Study Record Dates

• First Submitted: December 22, 2024
• First Posted: January 10, 2025
• Study Start: January 10, 2025
• Primary Completion: January 10, 2026
• Study Completion (Estimated): January 10, 2027
• Last Updated: January 10, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share