4-step ASCOT in POI Women to Promote Follicular Rescue

Premature Ovarian Insufficiency Clinical Trial

Official title:

4-step ASCOT in POI Women to Promote Follicular Rescue

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04475744
• Other study ID #: 1912-FIVI-113-SH
• Status: Completed
• Phase: Phase 3
• Start date: March 5, 2021
• Est. completion date: October 30, 2023

Study information

• Verified date: September 2023
• Source: Fundación IVI
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: October 30, 2023
• Est. primary completion date: October 30, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 38 Years

Eligibility

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

Related Conditions & MeSH terms

• Menopause, Premature
• Premature Ovarian Insufficiency
• Primary Ovarian Insufficiency

Intervention

Drug:
• G-CSF treatment for Bone marrow derived stem cell Mobilization
Mobilization treatment. On the fifth day, collection will be started.

Procedure:
• Platelet Rich Plasma ovarian injection
Mobilized peripheral blood will be obtained to prepare the PRP for injection. Both ovaries will be injected when proper anatomical access can be assessed.

Locations

Country	Name	City	State
Spain	IVI Madrid	Madrid
Spain	IVI Valencia	Valencia

Sponsors (4)

Lead Sponsor	Collaborator
Fundación IVI	Hospital Universitario La Fe, Instituto Valenciano de Infertilidad, IVI VALENCIA, IVI Madrid

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	AFC	Follicular development assessed by antral follicular count between controls and treated patients after the 4-step ASCOT technique during the follow up period.	6-month
Secondary	FSH, AMH and E2 levels	hormone levels in plasma	6-month
Secondary	Number of COS and IVF cycle parameters for each patient, initiated before and after treatment.	COS and IVF cycle variables will be recorded if COS initiated	6-month
Secondary	Menses recovery (YES/NO)	If menses recovery is noted by patients should be informed and recorded	6-12 months
Secondary	Ovarian function (YES/NO)	Antral follicles detected by untrasound, menses recover and decrease in FSH levels will be considered as positive ovarian function	6-12 months