Recruiting PHASE1 Endometrium; Atrophy

New treatment option for Endometrium; Atrophy

Official title AD-SVF Therapy for Refractory Endometrial Infertility

ClinicalTrials.gov ID: NCT07230600

What this study is testing

What is AD-SVF?

AD-SVF is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for endometrium; atrophy.

Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.

What it's testing
The purpose of this study is to initially explore the efficacy of adipose-derived stromal vascular fraction (AD-SVF) therapy in the treatment of refractory endometrial infertility.
  • Phase 1: an early, usually small safety study

A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.

Who can take part

Ages 22 to 45, women only

You may be able to join if

  • refractory thin endometrium (endometrial thickness \< 6 mm on the day of ovulation or the day of endometrial transformation during a hormone...
  • Inability to undergo autologous bone marrow stem cells-scaffold (BMSC) transplantation due to failed bone marrow aspiration, or lack of significant...
  • with fertility intentions;
  • normal ovarian function or availability of cryopreserved embryos;
  • 18kg/m\^2 \< body mass index (BMI) \< 30kg/m\^2;

You likely can't join if

  • Chromosomal karyotype abnormalities in one spouse;
  • Severe endometriosis, uterine fibroids affecting the uterine cavity morphology, or uterine malformations;
  • Abnormalities in coagulation function, hepatic or renal function, or other underlying conditions deemed by the investigator to potentially impact the...
  • Contraindications for pregnancy;
  • Contraindications for hormonal cycle therapy;
  • History of pelvic tumors;
See the full eligibility criteria
Who can join
  • refractory thin endometrium (endometrial thickness \< 6 mm on the day of ovulation or the day of endometrial transformation during a hormone replacement cycle) and/or moderate to severe intrauterine adhesion;
  • Inability to undergo autologous bone marrow stem cells-scaffold (BMSC) transplantation due to failed bone marrow aspiration, or lack of significant effect following the BMSC treatment;
  • with fertility intentions;
  • normal ovarian function or availability of cryopreserved embryos;
  • 18kg/m\^2 \< body mass index (BMI) \< 30kg/m\^2;
What rules you out
  • Chromosomal karyotype abnormalities in one spouse;
  • Severe endometriosis, uterine fibroids affecting the uterine cavity morphology, or uterine malformations;
  • Abnormalities in coagulation function, hepatic or renal function, or other underlying conditions deemed by the investigator to potentially impact the study's progression (uncontrolled hypertension, diabetes, autoimmune...
  • Contraindications for pregnancy;
  • Contraindications for hormonal cycle therapy;
  • History of pelvic tumors;
  • Simultaneous participation in other clinical studies.

The study team makes the final eligibility decision.

Where it's taking place

  • Nanjing, Jiangsu, China

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling female, 22 years to 45 years. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include Nanjing, Jiangsu, China. Enter your location above to see the nearest site and check your eligibility.

Explore other conditions

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.