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Follistatin 315

Activin-Binding Protein, FSH-Suppressing Protein, FST-315, FS-315

Quick Stats
Studies 14
Trials 93
Terminated PHASE2 INTERVENTIONAL NCT01343368

Preservation of Ovarian Function After Hematopoietic Cell Transplant

View on ClinicalTrials.gov Updated Dec 15, 2025

Brief Summary

Women undergoing myeloablative allogeneic hematopoietic cell transplant (MA HCT) will receive GnRH agonist leuprolide. Women undergoing reduced intensity allogeneic (RIC) HCT will be observed.

Detailed Description

This study is to use gonadotropin releasing hormone (GnRH) agonist leuprolide prior myeloablative hematopoietic cell transplantation to prevent ovarian dysfunction in post-menarchal women. The primary objective is to determine the effect of GnRH agonists on the incidence of ovarian failure. The secondary objectives are * to determine how effective GnRH agonists are at suppressing menses during * to determine the incidence and timing of resumption of menstrual cycles after HCT * to determine the incidence and timing of resumption of normal FSH and LH levels after HCT * to determine the incidence of normal AMH levels after HCT * to determine the effect of GnRH agonists on immune reconstitution after HCT * to assess the safety and tolerability of GnRH agonists in the context of HCT A total of 47 patients will be accrued in this study.

Interventions

Name: Leuprolide
Type: DRUG
Description: Long-acting leuprolide 11.25 mg intramuscularly (IM) pre-transplant (HCT) and 3 months post-HCT PLUS Short-acting leuprolide 0.2 mg subcutaneously (SQ) daily for 14 days
Name: hematopoietic cell transplant
Type: BIOLOGICAL
Description: Conventional bone marrow transplant regimen.
Name: reduced intensity allogeneic HCT
Type: BIOLOGICAL
Description: A reduced-intensity conditioning transplant is a bone marrow or cord blood transplant (also called a BMT) that uses less intense treatment to prepare for transplant than a standard transplant does. While a standard transplant uses the pre-transplant treatment to destroy most of the disease cells, a reduced-intensity transplant relies on the donor's immune cells to fight disease.

Primary Outcomes

Measure: Comparison of Number of Patients With Ovarian Failure
TimeFrame: Through Day 180 Post Transplant
Description: Comparison of treatment arms; interventional versus observational. Ovarian failure rate is based on FSH measured at 180 days after HCT; to determine the effect of GnRH agonists on the incidence of ovarian failure (i.e. FSH \>40 IU/L) after transplant.

Trial Information

NCT ID

NCT01343368

Status

Terminated

Study Type

INTERVENTIONAL

Phases

PHASE2

Sponsor

Masonic Cancer Center, University of Minnesota

Last Updated

December 15, 2025