Hyperbaric Oxygen in poor ovarian responders” - fertility evaluation

Not Applicable

• Conditions: poor ovarian responder; Infertility; Reproductive Health and Childbirth - Fertility including in vitro fertilisation

• Registration Number: ACTRN12621001671853
• Lead Sponsor: José Miguel Raimundo

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-12-06
• Last Update Posted: 13 December 2021

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: Female
• Target Recruitment: 40

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Pregnancy rate collected by participant fertility clinic records[1 month post completion of 28-day treatment cycle,]

Secondary Outcome Measures

Name	Time	Method
implantation rate collected by participant fertility clinic records[1 month post completion of 28-day treatment cycle];miscarriage rate collected by participant fertility clinic records[3 months post completion of 28-day treatment cycle];multiple pregnancy rate collected by participant fertility clinic records[2 months post completion of 28-day treatment cycle]