None listed
Conditions
Brief summary
Background: Hyperbaric oxygen (HBO) therapy is a treatment in which the patient is exposed to very high arterial and tissue oxygen pressure, during multiple sessions. It has been used as primary or adjunctive therapy for a variety of medical disorders. There are few studies focused on the effects of HBO treatment as an adjuvant for poor ovarian responders on assisted reproduction technology treatment. Aim: To evaluate the efficacy of hyperbaric oxygen therapy in the treatment of poor ovarian responders on assisted reproduction technology treatment. Design, Settings and Patients: Prospective cohort study. We propose the inclusion of 40 poor ovarian responder women on assisted fertilization program. The patients will be prospectively randomized into two groups based on the ovarian stimulation regimen used: group A (study group) (n=20) will be submitted to hyperbaric oxygen therapy for the first 7 days of stimulation with recombinant follicle stimulating hormone (rFSH) in a gonadotropin-releasing hormone antagonist protocol, and group B (control group) (n=20) will receive only a daily injection of rFSH in a gonadotropin-releasing hormone antagonist protocol. We will analyze the stimulation outcome and pregnancy and implantation rates.
Interventions
Group A (Intervention group) will be submitted to Hyperbaric Oxygen (HBO) therapy for the first 5 days of stimulation with recombinant follicle stimulating hormone (rFSH) in a gonadotropin-releasing hormone antagonist protocol
rFSH with 300 internacional unit (IU) /Day, Day 3 of the 28-day treatment cycle, until trigger (either recombinant human chorionic gonadotropin (hCG) 250 µg equivalent to 6,500 IU, or Gonadotrophin-releasing hormone agonists (GnRHa) triptorelin 0.2–0.4 mg) will be adminis
Group A (Intervention group) will be submitted to Hyperbaric Oxygen (HBO) therapy for the first 5 days of stimulation with recombinant follicle stimulating hormone (rFSH) in a gonadotropin-releasing hormone antagonist protocol rFSH with 300 internacional unit (IU) /Day, Day 3 of the 28-day treatment cycle, until trigger (either recombinant human chorionic gonadotropin (hCG) 250 µg equivalent to 6,500 IU, or Gonadotrophin-releasing hormone agonists (GnRHa) triptorelin 0.2–0.4 mg) will be administered as soon as two follicles reached a size of equal or greater than 17 mm. For the hormone treatment process participants will be allocated between recombinant hCG or GnRHa triptorelin per standard clinic protocol. All medication will be self-administrated by a diabetic-style pen. The adherence to the intervention will be monitored by laboratory tests and ultrasound. HBO consists of the administration of an inspired fraction of oxygen close to 1 (pure or 100% oxygen) via hood in a compressed chamber environment with a pressure higher (usually 2 to 3 times) than atmospheric pressure at sea level. This increase in pressure will result in a very significant increase in blood pressure and tissue oxygen (close to 2000 mmHg and 400 mmHg respectively), which will underlie most of the physiological and therapeutic effects of oxygen in a hyperbaric environment. The treatment will be done at a hyperbaric medicine centre by a qualified specialist in hyperbaric medicine, with a length of 1 hour in the morning of each day (from Days 1-5). The adherence to the intervention will be monitored by a daily attendance record.
Sponsors
José Miguel Raimundo
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
19 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
Inclusion criteria: poor ovarian responders “Bologna Criteria”: 1) advanced women’s age (greater than 40 years) or any other risk factor for POR; 2) recovering a few numbers of oocytes (less than 3 oocytes) following previous ovarian stimulation; 3) abnormal ovarian reserve test (antral follicle counts 5–7 or anti-Mullerian hormone 0.5–1.1 ng/mL). A poor responder is defined by the presence of two of these criteria.
Exclusion criteria
rFSH - recombinant follicle stimulating hormone • Prior hypersensitivity to recombinant FSH preparations or one of their excipients • High levels of FSH indicating primary gonadal failure • Uncontrolled thyroid or adrenal dysfunction • Sex hormone dependent tumors of the reproductive tract and accessory organs • An organic intracranial lesion such as a pituitary tumor • Abnormal uterine bleeding of undetermined origin (see Selection of Patients) • Ovarian cyst or enlargement of undetermined origin (see Selection of Patients) • Pregnancy Hyperbaric oxygen • Fever • Epilepsy • Pleural diseases: History of pneumothorax, post-pleurodesis status, thoracotomy or chest trauma with subsequent significant restriction of pleural mobility • Lung diseases: Bullous emphysema • Uncontrolled claustrophobia • Drugs: bleomycin; cisplatin, doxorubicin and disulfiram • Uncontrolled heart disease
Outcome results
None listed