Clinical trial NCT04475744: 4-step ASCOT in POI Women to Promote Follicular Rescue
Official title: 4-step ASCOT in POI Women to Promote Follicular Rescue
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Premature Ovarian Insufficiency
Lead sponsor: Fundación IVI
Sponsor class: OTHER
Collaborators: name: Instituto Valenciano de Infertilidad, IVI VALENCIA
name: IVI Madrid
name: Hospital Universitario La Fe
First posted: 2020-07-17
Enrollment: 42
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 38
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* Subjects who meet the following will be considered eligible to participate in the clinical trial:

  1. Informed consent form dated and signed.
  2. Age between 18 and 38 (both inclusive)
  3. 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:

  1. Simultaneous participation in another clinical study that, at the researcher's criteria, could interfere with the results of this study.
  2. Age ≥ 39
  3. Autoimmune origin of POI
  4. Genetic risk factors for POR (e.g. Turner Syndrome, FMR1 premutation, etc);
  5. Acquired conditions associated with POR (e.g. Chemotherapy);
  6. Clinical endometriosis
  7. Previous ovarian surgery considered as a risk of POR
  8. Previous gonadotoxic treatment
  9. Known intolerance or allergic reactions to components of the study product, i.e. lactose

Primary outcomes:
measure: AFC
timeFrame: 6-month
Secondary outcomes:
measure: FSH, AMH and E2 levels
timeFrame: 6-month
measure: Number of COS and IVF cycle parameters for each patient, initiated before and after treatment.
timeFrame: 6-month
measure: Menses recovery (YES/NO)
timeFrame: 6-12 months
measure: Ovarian function (YES/NO)
timeFrame: 6-12 months
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: IVI Madrid
city: Valencia
country: Spain
facility: IVI Valencia
Study officials:
References: