Thai women age 18-42 years diagnosed with infertility and classified as POSEIDON group 3 or 4 poor ovarian response, POSEIDON3/4
Conditions
Interventions
Pretreatment transdermal testosterone gel 25 mg apply daily for 21 consecutive days prior to expected menstruation. Then patient with enter controlled ovarian stimulation with standard protocol.,Pretr
transdermal testosterone gel 25 mg daily,transdermal testosterone gel 12.5 mg daily,Placebo gel
Sponsors
Faculty of medicine, Siriraj Hospital, Mahidol university
Eligibility
Sex/Gender
Female
Age
18 Years to 42 Years
Inclusion criteria
Inclusion criteria: 1 Thai women aged 18 - 42 years 2 Diagnosed with infertility, defined as inability to conceive despite regular unprotected intercourse for 12 months or 6 month for women aged 35 year and above. 3 Regular menstrual cycle with a cycle length of 21-35 days 4 Classifed under POSEIDON group 3 or 4 (having AMH level <1.2 ng/ml and/or AFC<5)
Exclusion criteria
Exclusion criteria: 1 Previous testosterone use within 3 months prior to the study 2 Untreated cause of infertility such as thyrotoxicosis or hyperprolactinemia 3 uncontrolled chronic disease or conditions where pregnancy is not recommended including uncontrolled DM/HT or uterine cancer, ovarian cancer or breast cancer 4 Allergic to transdermal testosterone gel 5 presence of certain medical conditions that contraindicate to testosterone use such as polycythemia (Hct>55%), unstable coronary artery disease, OSA, end-stage chronic liver disease 6 severe male infertility such as azoospermia and severe oligozoospermia
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of oocyte retrieved A controlled ovarian stimulation cycle after pretreatment transdermal or placebo gel numerical number | — |
Secondary
| Measure | Time frame |
|---|---|
| total dose of gonadotropins A controlled ovarian stimulation cycle after pretreatment transdermal or placebo gel international unit,total duration of stimulation A controlled ovarian stimulation cycle after pretreatment transdermal or placebo gel days,number of MII oocytes A controlled ovarian stimulation cycle after pretreatment transdermal or placebo gel numerical number,number of grade A blastocyst A controlled ovarian stimulation cycle after pretreatment transdermal or placebo gel numerical number,number of grade B and C blastocyst A controlled ovarian stimulation cycle after pretreatment transdermal or placebo gel numerical number,intrafollicular fluid of AMH and BMP-15 protein concentration A controlled ovarian stimulation cycle after pretreatment transdermal or placebo gel arbitrary unit,clinical pregnancy rate within 6 month of intervention using the embryo from the intervention cycle transvaginal ultrasound prove of intrauterine gestational sac or yolk sac or embryo,serum total testosterone level baseline before treatment and during treatment (7-10 days after intervention) ng/ml,adverse outcome after using testosterone gel end of intervention question by investigator | — |
Countries
Thailand
Contacts
Public ContactSirikul Tanpong
Faculty of medicine Siriraj Hospital, Mahidol university
Outcome results
None listed