Testosterone TRANSdermal Gel for Poor Ovarian Responders Trial (T-TRANSPORT)
Infertility, Poor Ovarian Response
About this trial
This is an interventional treatment trial for Infertility
Eligibility 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:
- All subjects must sign the Informed consent documents prior to screening evaluations.
- Age: between 18-43 years old.
- 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:
- Perimenopausal women with amenorrhea not having a regular cycle
- Basal FSH >20 IU/l
- Uterine malformations
- Recent history of any current untreated endocrine abnormality
- Unilateral or bilateral hydrosalpinx (visible on USS, unless clipped)
- Contraindications for the use of gonadotropins
- Recent history of severe disease requiring regular treatment
- Use of androgens during the last 3 months
- Patients with SHBG values <20nmol/L or >160nmol/L
- Azoospermia (sperm derived through FNA or TESE)
Sites / Locations
- UZ Antwerp
- Universitair Ziekenhuis BrusselRecruiting
- Fertility Clinic Rigshospitalet
- The Fertility Clinic, Skive Regional Hospital, Skive, DenmarkRecruiting
- Hospital Universitario Quiron DexeusRecruiting
- Hospital Universitario 12 de OctubreRecruiting
- Hospital Universitario HM MonteprincipeRecruiting
- Hospital Universitario La PazRecruiting
- Hospìtal Universitario HM Puerta del SurRecruiting
- Quiron Madrid HospitalRecruiting
- University Hospital BaselRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Transdermal testosterone gel
Placebo transdermal gel
Patients will receive once daily application of 0.55 gr TTG (Testosterone gel 1%; Laboratories Besins International,Paris,France) with a 5.5 mg/d nominal delivery rate of testosterone starting from day 1 or 2 of the following menstrual cycle, for approximately 65 days. Pituitary down-regulation will be induced by daily injections of 0.1mg triptorelin started on day 21 of the next cycle following enrollment in the study, up to and including the day of hCG administration. After 2 weeks of down-regulation, daily SC injections of HP-hMG (Menopur®) (300 IU/day) will be administered up to the day of hCG administration. Ovulation triggering will be induced with 250μg rhCG (Ovidrelle®) followed by oocyte pick-up ~36 hours later and ICSI. A maximum of 2 embryos, following each center's national criteria of single embryo transfer, will be transferred 3 days later. Luteal phase support with be performed with progesterone tablets ( Utrogestan®) (200mg x3, intravaginally).
Patients will receive once daily application of 0.55 gr identical placebo gel starting from day 1 or 2 of the following menstrual cycle, for approximately 65 days. Pituitary down-regulation will be induced by daily injections of 0.1mg triptorelin started on day 21 of the next cycle following enrollment in the study, up to and including the day of hCG administration. After 2 weeks of down-regulation, daily SC injections of HP-hMG (Menopur®) (300 IU/day) will be administered up to the day of hCG administration. Ovulation triggering will be induced with 250μg rhCG (Ovidrelle®) followed by oocyte pick-up ~36 hours later and ICSI. A maximum of 2 embryos, following each center's national criteria of single embryo transfer, will be transferred 3 days later. Luteal phase support with be performed with progesterone tablets ( Utrogestan®) (200mg x3, intravaginally).