CompletedNot Applicable

Surgical Sperm Retrieval in Non-obstructive Azoospermic Men: mTESE vs. TESA

Denmark, Sweden110 participantsStarted 2017-04-01

Plain-language summary

Infertility is a significant social- and health problem in the Western World and at the moment in Denmark one in ten babies are born with the help of assisted reproduction. In 50% of infertile couples a male factor can be identified as a contributing cause (1). Azoospermia is defined as the absence of spermatozoa in the ejaculate and it is a condition affecting 10-15% of infertile men (2, 3). Azoospermia is divided into obstructive azoospermia (OA) and nonobstructive azoospermia (NOA) of which the latter constitutes 60% (2, 3). In NOA the production of spermatozoa in the testis is either absent or markedly decreased. Since 1999 microdissection testicular sperm extraction (mTESE) has become the preferred treatment option for NOA in many centers worldwide (4). The procedure is performed in general anesthesia using an operating microscope to carefully examine the entire testicular tissue for the presence of spermatozoa which can be used for assisted reproduction. An alternative to mTESE is a percutaneous testicular sperm aspiration (TESA) or needle biopsy. This procedure is simple to perform using a biopsy needle to aspirate testicular tissue. The aspirated tissue is examined for the presence of spermatozoa that can be used in assisted reproduction. Today there is no robust evidence on the optimal sperm retrieval protocol on men with NOA. This is in part due to the fact that no randomized trials have been performed to compare procedures. This study is the first to randomize procedures for surgical sperm retrieval. Hypothesis In men with NOA, the investigators hypothesize that TESA is a viable first line approach compared to mTESE in regards to success rates of finding spermatozoa, complication rates and pregnancy outcomes. A total of 110 men will be randomized to either mTESE or TESA and the rates of finding spermatozoa will be compared. However, for ethical reasons, because some believe mTESE have a greater chance of finding sperm cells, all men with a failed TESA will have a mTESE afterwards.

Who can participate

Age range18 Years – 70 Years

SexMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Azoospermia verified in at least two semen samples within the past six months, including assessment of the centrifuged pellet as per the WHO 5th edition (13) * Testis volume (Prader's orchidometer) ≤ 15ml on both sides * No indication of obstructive causes of azoospermia in medical history or physical examination (ex. absent vas deferens, vasectomy, scrotal trauma/injury, hernia repair or other operations potentially damaging the vas deferens) * Capable and legally competent individual Exclusion Criteria: * Previous attempts of surgical sperm retrieval * Previous testicular biopsy * Anejaculation * Retrograde ejaculation * Bleeding disorders rendering surgery too high a risk * Klinefelters Syndrome * XX male * AZFa/b microdeletion * CFTR mutation * Inability to understand and/or stick to the written information * Patients not deemed suitable for general anesthesia Exclusion during follow-up * A patient can at any time during the study withdraw their consent of participation * Normal histology on testis biopsy following TESA or mTESE

What they're measuring

Sperm retrieval rate

Timeframe: Assessed immediately after the procedure

Trial details

NCT IDNCT03550716

SponsorHerlev and Gentofte Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2020-10-30