Testosterone TRANSdermal Gel for Poor Ovarian Responders Trial

• Status: Recruiting
• Trial end date: 2023-06-01
• Target enrollment: 0
• Participant gender: Female

Summary

Previous work indicates that 2 months androgen pre-treatment may equip preantral follicles with more FSH receptors and increase the cohort of follicles surviving to the recruitable antral stage. In this regard it may result in an increase in the oocyte yield and the reproductive outcome in women with poor ovarian response. These findings provide a strong rationale for a definitive large RCT. The TTRANSPORT study will include 400 women with poor ovarian response randomized to receive pre-treatment with transdermal testosterone gel or placebo in order to provide conclusive evidence regarding the superiority or not of transdermal testosterone pre-treatment for the management of poor ovarian responders fulfilling the Bologna criteria.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Institut Universitari Dexeus; Universitair Ziekenhuis Brussel
• Treatments: Methyltestosterone; Polystyrene sulfonic acid; Testosterone; Testosterone 17 beta-cypionate; Testosterone enanthate; Testosterone undecanoate; Triptorelin Pamoate

Criteria

Inclusion Criteria:

Patients participating in the TTRANSPORT study will be women who are considered poor ovarian responders according to the "Bologna criteria" (Ferraretti et al., 2011).

Subjects must fulfil the following criteria to be included in the study:

1. All subjects must sign the Informed consent documents prior to screening evaluations.

2. Age: between 18-43 years old.

3. One of the features below:

Infertile female <40 years old with i. ≤ 3 oocytes in a previous cycle and AFC <7 OR ii. ovarian surgery/chemotherapy and AFC<7 OR iii. ≤ 3 oocytes in at least 2 previous cycles with ≥300IU gonadotropins

Infertile female ≥40 years old with i. ≤ 3 oocytes in a previous cycle OR ii. AFC <7. Patients will be randomized according to different age groups (<36, 36-39 and ≥40 years old).

Exclusion Criteria:

1. Perimenopausal women with amenorrhea not having a regular cycle

2. Basal FSH >20 IU/l

3. Uterine malformations

4. Recent history of any current untreated endocrine abnormality

5. Unilateral or bilateral hydrosalpinx (visible on USS, unless clipped)

6. Contraindications for the use of gonadotropins

7. Recent history of severe disease requiring regular treatment

8. Use of androgens during the last 3 months

9. Patients with SHBG values <20nmol/L or >160nmol/L

10. Azoospermia (sperm derived through FNA or TESE)