Evidence map›Paper›PMID 41827043›Full record

ArticleTrials2026

Granulocyte-macrophage colony-stimulating factor-containing medium for blastocyst recovery culture: study protocol for a randomized controlled trial (GSET-study).

Tatsuya Kobayashi, Kyoko Higuchi, Miki Okabe-Kinoshita, Kayoko Kikuchi, Tomoya Kurokawa, Shota Hatakeyama, Tsuyoshi Okubo, Shota Oikawa, Ryosuke Suzuki, Seiji Ogawa and 11 more

Abstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in Trials, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

21 authors.

Tatsuya Kobayashi *Haneda Clinic, Reproduction Center, Fujita Health University, 1-1-4 Hanedakuko, Ota-Ku, Tokyo, 144-0041, Japan. tatsuya.kobayashi@fujita-hu.ac.jp.ORCID http://orcid.org/0000-0001-5072-6756
Kyoko Higuchi *Haneda Clinic, Reproduction Center, Fujita Health University, 1-1-4 Hanedakuko, Ota-Ku, Tokyo, 144-0041, Japan.
Miki Okabe-KinoshitaTakahashi Women's Clinic, 18-14-6F Shinmachi, Chuo-Ku, Chiba, 260-0028, Japan.
Kayoko KikuchiTranslational Research Headquarters, Fujita Health University, 1-98 Dengakugakubo, Kutsukake-Cho, Toyoake, Aichi, 470-1192, Japan.
Tomoya KurokawaDivision of Clinical Research Center, Chiba University Hospital, 1-8-1 Inohana, Chuo-Ku, Chiba, 260-8677, Japan.
Shota HatakeyamaYanaihara Women's Clinic, 1-24-30-4F Ofuna, Kamakura, Kanagawa, 247-0056, Japan.
Tsuyoshi OkuboShinbashi Yume Clinic, 2-5-1, Shinbashi, Minato-Ku, Tokyo, 105-0004, Japan.
Shota OikawaClinical Laboratory Division, Fujita Health University Hospital, 1-98 Dengakugakubo, Kutsukake-Cho, Toyoake, Aichi, 470-1192, Japan.
Ryosuke SuzukiKanagawa Ladies Clinic, 1-11-5 Nishikanagawa, Kanagawa-Ku, Yokohama, Kanagawa, 221-0822, Japan.
Seiji OgawaHaneda Clinic, Reproduction Center, Fujita Health University, 1-1-4 Hanedakuko, Ota-Ku, Tokyo, 144-0041, Japan.
Goro KuramotoHaneda Clinic, Reproduction Center, Fujita Health University, 1-1-4 Hanedakuko, Ota-Ku, Tokyo, 144-0041, Japan.
Akiko KadaCenter for Translational Research, Fujita Health University, 1-98 Dengakugakubo, Kutsukake-Cho, Toyoake, Aichi, 470-1192, Japan.
Shigeto ShimmuraDepartment of Clinical Regenerative Medicine, Fujita Medical Innovation Center, 1-1-4 Hanedakuko, Ota-Ku, Tokyo, 144-0041, Japan.
Akihiro MouriResearch Promotion Unit, Department of Regulatory Science, School of Medical Sciences, Fujita Health University, 1-98 Dengakugakubo, Kutsukake-Cho, Toyoake, Aichi, 470-1192, Japan.
Atsushi YanaiharaYanaihara Women's Clinic, 1-24-30-4F Ofuna, Kamakura, Kanagawa, 247-0056, Japan.
Tomoya SegawaShinbashi Yume Clinic, 2-5-1, Shinbashi, Minato-Ku, Tokyo, 105-0004, Japan.
Atsushi YamamotoKanagawa Ladies Clinic, 1-11-5 Nishikanagawa, Kanagawa-Ku, Yokohama, Kanagawa, 221-0822, Japan.
Eiji NishioDepartment of Obstetrics and Gynecology, School of Medicine, Fujita Health University, 1-98 Dengakugakubo, Kutsukake-Cho, Toyoake, Aichi, 470-1192, Japan.
Keiichi TakahashiTakahashi Women's Clinic, 18-14-6F Shinmachi, Chuo-Ku, Chiba, 260-0028, Japan.
Haruki NishizawaDepartment of Obstetrics and Gynecology, School of Medicine, Fujita Health University, 1-98 Dengakugakubo, Kutsukake-Cho, Toyoake, Aichi, 470-1192, Japan.
Toshio HamataniHaneda Clinic, Reproduction Center, Fujita Health University, 1-1-4 Hanedakuko, Ota-Ku, Tokyo, 144-0041, Japan.

Funding

Fujita Health University FY2024Takeda Medical Research Foundation 2024042820.
6 · The paper itself

Abstract

backgroundAlthough the number of frozen-thawed blastocysts transfer is increasing worldwide, the live birth rate following blastocyst transfer using assisted reproductive technology remains at 30-60%. Thus, improving the pregnancy rate per transfer is an urgent issue. In a previous retrospective study, we evaluated the use of granulocyte-macrophage colony-stimulating factor (GM-CSF)-containing medium for recovery culture to improve the outcomes of frozen-thawed blastocyst transfers. The results demonstrated that the live birth rates increased by approximately 10% following recovery culture in the GM-CSF-containing culture medium. This study aims to prospectively evaluate whether GM-CSF-containing blastocyst recovery culture following thawing increases live birth.

methodsThis is a multicenter, randomized, parallel-group, active-controlled, single-blind trial. The recruitment target is 750 participants meeting the criteria. Enrolled patients are randomized 1:1 to the GM-CSF-containing culture medium group (test group) or the non-GM-CSF-containing culture medium group (control group). The blastocyst recovery culture after warming was defined as an intervention in this study; frozen-thawed blastocysts will be cultured for 3-7 h in GM-CSF-containing medium (test group) or medium without GM-CSF (control group) followed by blastocyst transfer. The primary outcome will be live birth. We will also evaluate embryo transfer outcomes as secondary efficacy endpoints and evaluate perinatal and neonatal outcomes as a safety endpoint. DISCUSSION: This is the first large-scale prospective study to investigate the efficacy of a GM-CSF-containing medium for frozen-thawed blastocyst transfer. The study findings will provide evidence regarding the efficiency of GM-CSF-containing medium for blastocyst recovery culture after warming.

trial registrationJapan Registry of Clinical Trials jRCT1040240159. Registered on January 6, 2025.

Indexed as

BlastocystCulture MediaEmbryo Culture TechniquesEmbryo TransferGranulocyte-Macrophage Colony-Stimulating FactorAdultCryopreservationFemaleHumansLive BirthMulticenter Studies as TopicPregnancyPregnancy RateProspective StudiesRandomized Controlled Trials as TopicSingle-Blind MethodCulture MediaGranulocyte-Macrophage Colony-Stimulating FactorBlastocyst transferCryopreservationCulture MediaCytokinesFemaleGranulocyte–Macrophage Colony-Stimulating FactorInfertilityLive birthPregnancy RateRandomized clinical trial

Identifiers

PMID41827043
PMCPMC13097834

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.