ProFertil study protocol for the investigation of gonadotropin-releasing hormone agonists (GnRHa) during chemotherapy aiming at fertility protection of young women and teenagers with cancer in Sweden-a phase III randomised double-blinded placebo-controlled study.
Rodriguez-Wallberg. Kenny A KA; Nilsson. Hanna Pauline HP; Bergh. Jonas J; Malmros. Johan J; Ljungman. Per P; Foukakis. Theodoros T; Stragliotto. Christina Linder CL; Friman. Erika Isaksson EI; Linderholm. Barbro B; Valachis. Antonis A; Andersson. Anne A; Harrysson. Sara S; Vennström. Lovisa L; Frisk. Per P; Mörse. Helena H; Eloranta. Sandra S
Key Findings
- It’s a double‑blind, placebo‑controlled phase III trial with 300 breast‑cancer patients and 200 patients with other cancers
- Participants will receive triptorelin or placebo throughout gonadotoxic chemotherapy
- The main outcome will be how well anti‑Müllerian hormone (AMH) levels recover 12 months after treatment
Practical Outcomes
- At this stage the study only outlines the design, so biohackers and self‑experimenters can’t change any protocols yet. It does signal that solid evidence on triptorelin for fertility protection is still pending, and they should wait for the trial results before considering it for personal use.
Summary
This abstract describes a planned clinical trial testing whether the hormone drug triptorelin can protect young women’s fertility during chemotherapy, but it doesn’t provide any results yet, so there’s nothing concrete to act on right now.
Abstract
Gonadotropin-releasing hormone agonists (GnRHa) cotreatment used to transiently suppress ovarian function during chemotherapy to prevent ovarian damage and preserve female fertility is used globally but efficacy is debated. Most clinical studies investigating a beneficial effect of GnRHa cotreatment on ovarian function have been small, retrospective and uncontrolled. Unblinded randomised studies on women with breast cancer have suggested a beneficial effect, but results are mixed with lack of evidence of improvement in markers of ovarian reserve. Unblinded randomised studies of women with lymphoma have not shown any benefit regarding fertility markers after long-term follow-up and no placebo-controlled study has been conducted so far. The aim of this study is to investigate if administration of GnRHa during cancer treatment can preserve fertility in young female cancer patients in a double-blind, placebo-controlled clinical trial. A prospective, randomised, double-blinded, placebo-controlled, phase III study including 300 subjects with breast cancer. In addition, 200 subjects with lymphoma, acute leukemias and sarcomas will be recruited. Women aged 14-42 will be randomised 1:1 to treatment with GnRHa (triptorelin) or placebo for the duration of their gonadotoxic chemotherapy. Follow-up until 5 years from end of treatment (EoT). The primary endpoint will be change in anti-Müllerian hormone (AMH) recovery at follow-up 12 months after EoT, relative to AMH levels at EoT, comparing the GnRHa group and the placebo group in women with breast cancer. This study is designed in accordance with the principles of Good Clinical Practice (ICH-GCP E6 (R2)), local regulations (ie, European Directive 2001/20/EC) and the ethical principles of the Declaration of Helsinki. Within 6 months of study completion, the results will be analysed and the study results shall be reported in the EudraCT database. The National Institutional review board in Sweden dnr:2021-03379, approval date 12 October 2021 (approved amendments 12 June 2022, dnr:2022-02924-02 and 13 December 2022, dnr:2022-05565-02). The Swedish Medical Product Agency 19 January 2022, Dnr:5.1-2021-98927 (approved amendment 4 February 2022). Manufacturing authorisation for authorised medicinal products approved 6 December 2021, Dnr:6.2.1-2020-079580. Stockholm Medical Biobank approved 22 June 2022, RBC dnr:202 253. NCT05328258; EudraCT number:2020-004780-71.
Study Information
pubmed
2023
2023-12-09T00:00:00.000Z
10.1136/bmjopen-2023-078023
5
28