Infertility in women with poor ovarian response to stimulation for IVF/ICSI MedDRA version: 20.0 Level: PT Classification code 10021928 Term: Infertility female System Organ Class: 10038604 - Reproductive system and breast disorders
Conditions
Interventions
Trade Name: ANDROGEL
Product Name: Androgel
Pharmaceutical Form: Transdermal gel
INN or Proposed INN: TESTOSTERONE
CAS Number: 58-22-0
Concentration unit: mg milligram(s)
Concentration type: equal
Con
Sponsors
Fundación Santiago Dexeus Font (Dexeus)
Eligibility
Sex/Gender
All
Inclusion 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 =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
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 160nmol/L 10.Azoospermia (sperm derived through FNA or TESE)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Clinical pregnancy rate defined as the presence of intrauterine gestational sac with an embryonic pole demonstrating cardiac activity at 7 weeks of gestation;Secondary Objective: a.Ongoing pregnancy rate defined as the presence of intrauterine gestational sac with an embryonic pole demonstrating cardiac activity at 9-10 weeks of gestation b.Biochemical pregnancy defined as positive pregnancy test 2 weeks after embryo transfer c.Number of oocytes retrieved after oocyte retrieval before ICSI d.Cycle cancellation due to poor response e.Number of cycles reaching the stage of embryo transfer f.Number and quality of embryos g.Number of cycles with frozen supernumerary embryos h.Cycle cancellation due to adverse effects of medication ;Primary end point(s): The primary efficacy endpoint is the clinical pregnancy rates, defined as defined as the presence of intrauterine gestational sac with an embryonic pole demonstrating cardiac activity at 7 weeks of gestation. The primary efficacy endpoint is related to the primary trial objective.;Timepoint(s) of evaluation of this end point: 7 weeks of gestation | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The key secondary endpoints are: 1.Cycle cancellation due to poor ovarian response 2.Cycles with embryo transfer 3.Ongoing pregnancy rate (the presence of intrauterine gestational sac with an embryonic pole demonstrating cardiac activity at 9-10 weeks of gestation) 4.Biochemical pregnancy (defined as positive pregnancy test 2 weeks after embryo transfer) 5.Number of cumulus oocyte complexes (COCs) retrieved 6.Number of MII oocytes retrieved ;Timepoint(s) of evaluation of this end point: 1. 9-10 weeks of gestation 2. 2 weeks after embryo transfer 3. 10 -20 days from initiation of ovarian stimulation 4. 10-20 days from initiation of ovarian stimulation 5. 10 days after initiation of daily injections of HP-hMG 6. 10-20 days from initiation of ovarian stimulation | — |
Countries
Belgium, Denmark, Spain, Switzerland
Contacts
Public ContactClinical Trial Information
BioClever 2005 S.L.
Outcome results
None listed