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OpenTrials
Completed

NCT Number: NCT04475744

4-step ASCOT in POI Women to Promote Follicular Rescue

To promote follicular development in POI women, G-CSF mobilized activated platelet rich plasma will be directly injected into the ovarian medulla.

This is a prospective, observational, multicentric, open, pilot-controlled randomized trial which seeks to evaluate the impact of the 4-step ASCOT technique on the ovarian reserve and reproductive outcomes of POI patients. The study will be developed in two phases.

In a first step, POI women will randomized to control or undergo the 4-step ASCOT technique based on the direct ovarian injection of G-CSF mobilized and activated PRP. Follow up (AFC, AMH, FSH and E2 determinations) will be developed for 3 month in the controls and for 6 months in the treated and COS initiated if growing antral follicles detected. In the second phase, POI women allocated to control group after completed the follow up period will undergo the 4-step ASCOT technique, as described in the previous phase but only one ovary will be injected, then they will undergo a 6-month follow up period as described above.

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Key information

Conditions

Premature Ovarian Insufficiency Adnexal Diseases Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Gonadal Disorders Ovarian Diseases Primary Ovarian Insufficiency Urogenital Diseases

Age range

18 year–38 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

IVI Madrid, Madrid, Spain

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Subjects who meet the following will be considered eligible to participate in the clinical trial:
  • Informed consent form dated and signed.
  • Age between 18 and 38 (both inclusive)
  • Women who meet the ESHRE criteria for POI [41]
  • presence of menstrual disturbance defined as oligo/amenorrhea for at least 4 months
  • biochemical confirmation as evidenced by an elevated FSH level >25IU/L on two occasions > 4 weeks apart
  • Or fluctuating POI when one of the above criteria is missing.

Exclusion criteria

  • Subjects who meet one or more of the following will not be considered eligible to participate in the clinical trial:
  • Simultaneous participation in another clinical study that, at the researcher's criteria, could interfere with the results of this study.
  • Age ≥ 39
  • Autoimmune origin of POI
  • Genetic risk factors for POR (e.g. Turner Syndrome, FMR1 premutation, etc);
  • Acquired conditions associated with POR (e.g. Chemotherapy);
  • Clinical endometriosis
  • Previous ovarian surgery considered as a risk of POR
  • Previous gonadotoxic treatment
  • Known intolerance or allergic reactions to components of the study product, i.e. lactose

Treatment and study plan

G-CSF treatment for Bone marrow derived stem cell Mobilization

Drug

Mobilization treatment. On the fifth day, collection will be started.

Platelet Rich Plasma ovarian injection

Procedure

Mobilized peripheral blood will be obtained to prepare the PRP for injection. Both ovaries will be injected when proper anatomical access can be assessed.

Primary outcomes

  1. AFC

    Time frame: 6-month

    Follicular development assessed by antral follicular count between controls and treated patients after the 4-step ASCOT technique during the follow up period.

Secondary outcomes

  1. FSH, AMH and E2 levels

    Time frame: 6-month

    hormone levels in plasma

  2. Number of COS and IVF cycle parameters for each patient, initiated before and after treatment.

    Time frame: 6-month

    COS and IVF cycle variables will be recorded if COS initiated

  3. Menses recovery (YES/NO)

    Time frame: 6-12 months

    If menses recovery is noted by patients should be informed and recorded

  4. Ovarian function (YES/NO)

    Time frame: 6-12 months

    Antral follicles detected by untrasound, menses recover and decrease in FSH levels will be considered as positive ovarian function

Sponsors and collaborators

Lead sponsor

Fundación IVI

Other

Collaborators

  • Hospital Universitario La Fe
  • IVI Madrid
  • Instituto Valenciano de Infertilidad, IVI VALENCIA

Registry information

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Jul 17, 2020
Registry last updated
Feb 28, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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