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The Impact of Granulocyte Colony Stimulating Factor on Premature Ovarian Insufficiency

Recruiting
25 - 40 years of age
Female
Phase 2

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Overview

The goal of this pilot study is to improve ovarian reserve markers in patients with premature ovarian insufficiency. The main question it aims to answer is:

  • Will treatment with G-CSF allow improvement in markers of ovarian reserve?

Description

The research team hypothesize that treatment of premature ovarian insufficiency patients with G-CSF to mobilize bone marrow hematopoietic stem cells will allow for improved ovarian reserve markers including antral follicle count, anti-Mullerian hormone (AMH) levels and gonadotropin (FSH) levels. The research team anticipate these outcomes:

  • Primary outcome: Decreased serum FSH and increased AMH levels and u/s measurement of increased antral follicle count (AFC)
  • Secondary outcome: Improved ovarian response in IVF cycles if BAFs develop, and spontaneous or IVF pregnancy.

Eligibility

Inclusion Criteria:

  • Women ages 25-40
  • Woman who meet criteria for POI defined as AFC < 5, AMH < 3 pmol/L and FSH >30 IU/L. There may also be associated symptoms of the menopause such as hot flushes, night sweats, insomnia and vaginal dryness.
  • Women who are not taking any other medical or fertility treatments except natural estrogen to stop hot flushes.
  • Those who are provided with informed consent.

Exclusion Criteria:

  • Women with age > 40
  • Women with history of autoimmune disorders
  • Women with a history of hematopoietic cell malignancies
  • Women with sickle cell disease
  • Women with any other comorbidities that would preclude infertility treatment and pregnancy such as HIV/AIDS, hepatitis B or C, breast cancer or body mass index (BMI) >40.

Study details

Primary Ovarian Insufficiency, Premature Ovarian Failure

NCT06117982

Trio Fertility

14 February 2024

Step 1 Get in touch with the nearest study center
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  • You can expect the study team to contact you via email or phone in the next few days.
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