Experience of using ovarian stimulation protocol with dienogest in patients with infertility and endometriosis

I.V. Gorelova, Makolkin A.A. Makolkin, L. I. Polyakova, Ksenia V. Chernoshtan, Vadim B. Mosyagin, O.S. Arnt, Alena A. Sokolova
In: Journal of obstetrics and women's diseases · 2025 · vol. 74(4) , pp. 5–13 · doi:10.17816/jowd678936 · W4415219662
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⚙ AI-generated summary by claude@2026-06, 2026-06-07 ⓘ

This study found that an ovarian stimulation protocol using dienogest in women with endometriosis and infertility yielded comparable embryo quality and pregnancy outcomes to GnRH agonist/antagonist protocols, with fewer reported adverse events than GnRH antagonists.

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This retrospective single-center cohort study evaluated the effectiveness and safety of ovarian stimulation protocols using continuous dienogest (2 mg/day) compared with IVF stimulation using GnRH agonists or GnRH antagonists in 49 couples (80 cycles) with surgically or imaging-confirmed endometriosis and infertility. Blastocysts were vitrified, and embryo transfers of thawed embryos occurred via modified natural or hormone replacement cycles; outcomes included cryopreservable embryo rates, euploidy after preimplantation genetic testing, clinical pregnancy rate and pregnancy outcomes, and reported drug side effects/complications. Ovarian stimulation outcomes and rates of embryo quality and PGT differed minimally across groups, with the main adverse reaction difference being more local reactions in the GnRH antagonist group; clinical pregnancy rate was higher in the dienogest group (75.0%) than the agonist (33.3%) and antagonist groups (20.0%; p = 0.023), and pregnancy outcomes did not differ significantly between groups. Limitations explicitly include the retrospective, single-center design. This paper is centrally about endometriosis — it assesses a dienogest-based ovarian stimulation approach for infertility treatment in women with endometriosis.

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Abstract

BACKGROUND: Endometriosis is most often characterized by two main clinical symptoms, namely, pelvic pain and infertility. Hormonal therapy may be prescribed to reduce the recurrence of the disease after surgical treatment and to relieve pain. It in most cases is incompatible with pregnancy planning and infertility treatment in in vitro fertilization programs. Currently, a protocol with various gestagens has been described for ovarian stimulation applicable in programs with cryopreservation of all embryos. However, there is scarce data on the use of such a protocol with dienogest that is widely used in the treatment of endometriosis. AIM: The aim of this study was to assess the effectiveness and safety of using a protocol of assisted reproductive technology with dienogest in patients with endometriosis and infertility. METHODS: This retrospective single-center cohort study included patients aged 18 to 45 years with infertility and endometriosis confirmed by surgical treatment or imaging methods (magnetic resonance imaging and ultrasound). The included couples underwent cycles of assisted reproductive technology with ovarian stimulation: with dienogest 2 mg/day continuously, with gonadotropin-releasing hormone agonists, and with gonadotropin-releasing hormone antagonists. All obtained blastocysts were cryopreserved by vitrification. Transfer of thawed embryos was performed in a modified natural cycle or with hormone replacement therapy. We assessed the frequency of obtaining embryos suitable for cryopreservation and euploid (according to the results of preimplantation genetic testing), as well as the frequency of pregnancy and its outcome. When assessing safety, side effects of the drugs used and the frequency of complications were monitored. RESULTS: 49 couples underwent 80 cycles of assisted reproductive technology with ovarian stimulation: dienogest was used in group 1 (n = 29); protocol with gonadotropin-releasing hormone agonists in group 2 (n = 9); and protocol with gonadotropin-releasing hormone antagonists in group 3 (n = 42). All obtained blastocysts were cryopreserved by vitrification (162 embryos in total). The average age of the patients was 37.99 ± 4.50 years. In group 3, women more often reported local adverse reactions after the introduction of gonadotropin-releasing hormone antagonists (p = 0.021). The study groups did not differ in the frequency of other adverse reactions such as abdominal pain, gastrointestinal symptoms, and headache (p = 0.823). The results of ovarian stimulation were comparable between all the study groups. In total, 31 embryo transfers were performed. The clinical pregnancy rate was 35.5% (95% confidence interval 19.2–54.6): 75.0% in group 1, 33.3% in group 2, and 20.0% in group 3 (p = 0.023). No differences were found in the analysis of pregnancy outcomes between the study groups (p = 0.118). The groups did not differ in the frequency of preimplantation genetic testing (p = 0.153) and embryo quality (p = 0.82). CONCLUSION: The ovarian stimulation protocol with dienogest allows for effective treatment of infertility in patients with endometriosis without discontinuing drug therapy for a long time.
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Abstract

BACKGROUND: Endometriosis is most often characterized by two main clinical symptoms, namely, pelvic pain and infertility. Hormonal therapy may be prescribed to reduce the recurrence of the disease after surgical treatment and to relieve pain. It in most cases is incompatible with pregnancy planning and infertility treatment in in vitro fertilization programs. Currently, a protocol with various gestagens has been described for ovarian stimulation applicable in programs with cryopreservation of all embryos. However, there is scarce data on the use of such a protocol with dienogest that is widely used in the treatment of endometriosis. AIM: The aim of this study was to assess the effectiveness and safety of using a protocol of assisted reproductive technology with dienogest in patients with endometriosis and infertility.

Methods

This retrospective single-center cohort study included patients aged 18 to 45 years with infertility and endometriosis confirmed by surgical treatment or imaging methods (magnetic resonance imaging and ultrasound). The included couples underwent cycles of assisted reproductive technology with ovarian stimulation: with dienogest 2 mg/day continuously, with gonadotropin-releasing hormone agonists, and with gonadotropin-releasing hormone antagonists. All obtained blastocysts were cryopreserved by vitrification. Transfer of thawed embryos was performed in a modified natural cycle or with hormone replacement therapy. We assessed the frequency of obtaining embryos suitable for cryopreservation and euploid (according to the results of preimplantation genetic testing), as well as the frequency of pregnancy and its outcome. When assessing safety, side effects of the drugs used and the frequency of complications were monitored.

Results

49 couples underwent 80 cycles of assisted reproductive technology with ovarian stimulation: dienogest was used in group 1 (n = 29); protocol with gonadotropin-releasing hormone agonists in group 2 (n = 9); and protocol with gonadotropin-releasing hormone antagonists in group 3 (n = 42). All obtained blastocysts were cryopreserved by vitrification (162 embryos in total). The average age of the patients was 37.99 ± 4.50 years. In group 3, women more often reported local adverse reactions after the introduction of gonadotropin-releasing hormone antagonists (p = 0.021). The study groups did not differ in the frequency of other adverse reactions such as abdominal pain, gastrointestinal symptoms, and headache (p = 0.823). The results of ovarian stimulation were comparable between all the study groups. In total, 31 embryo transfers were performed. The clinical pregnancy rate was 35.5% (95% confidence interval 19.2–54.6): 75.0% in group 1, 33.3% in group 2, and 20.0% in group 3 (p = 0.023). No differences were found in the analysis of pregnancy outcomes between the study groups (p = 0.118). The groups did not differ in the frequency of preimplantation genetic testing (p = 0.153) and embryo quality (p = 0.82).

Conclusion

The ovarian stimulation protocol with dienogest allows for effective treatment of infertility in patients with endometriosis without discontinuing drug therapy for a long time. Full Text About the authors Inga V. Gorelova Delta Fertility Clinic; Almazov National Medical Research Centre Author for correspondence. Email: [email protected] ORCID iD: 0000-0002-6098-1491 SPIN-code: 1207-5705 MD, Cand. Sci. (Medicine), Assistant Professor Russian Federation, Saint Petersburg; Saint PetersburgAleksandr A. Makolkin Delta Fertility Clinic Email: [email protected] ORCID iD: 0000-0001-8858-7333 MD Russian Federation, Saint PetersburgLada Igorevna Polyakova Almazov National Medical Research Centre Email: [email protected] Russian Federation, Saint Petersburg Ksenia V. Chernoshtan Delta Fertility Clinic Email: [email protected] MD Russian Federation, Saint PetersburgVadim B. Mosyagin Saint Petersburg State Pediatric Medical University Email: [email protected] SPIN-code: 2169-8330 MD, Dr. Sci. (Medicine), Professor Russian Federation, Saint PetersburgOlga S. Arnt Delta Fertility Clinic; Saint Petersburg State Pediatric Medical University Email: [email protected] ORCID iD: 0000-0003-1565-2012 SPIN-code: 1482-0917 MD, Cand. Sci. (Medicine), Assistant Professor Russian Federation, Saint Petersburg; Saint PetersburgAlena A. Efimova Almazov National Medical Research Centre Email: [email protected] ORCID iD: 0000-0003-3323-1561 SPIN-code: 2423-0370 MD Russian Federation, Saint PetersburgReferences - Endometriosis. Clinical guidelines of the Russian Society of Obstetricians and Gynecologists, 2024 [Internet]. [Updated 2024 Sep 25; cited 2025 Jan 9]. Available from: https://drive.google.com/file/d/14XuaZzgwocmmXOXVzeVT60QK4WokgbpH/view. (In Russ). - Prescott J, Farland LV, Tobias DK, et al. A prospective cohort study of endometriosis and subsequent risk of infertility. Hum Reprod. 2016;31(7):1475–1482. doi: 10.1093/humrep/dew085 - Ceccaroni M, Bounous VE, Clarizia R, et al Recurrent endometriosis: a battle against an unknown enemy. Eur J Contracept Reprod Health Care. 2019;24(6):464–474. EDN: DPHPAL doi: 10.1080/13625187.2019.1662391 - European Society of Human Reproduction and Embryology. Endometriosis. 2022. [cited 2025 Jan 9]. Available from: https://www.eshre.eu/Guideline/Endometriosis - Somigliana E, Viganò P, Benaglia L, et al. Ovarian stimulation and endometriosis progression or recurrence: a systematic review. Reprod Biomed Online. 2019;38(2):185–194. doi: 10.1016/j.rbmo.2018.11.021 - Female infertility. Clinical guidelines of the Russian Society of Obstetricians and Gynecologists, 2024 [Internet]. [Updated 2024 Jul 20; cited 2025 Jan 25]. Available from: https://drive.google.com/file/d/1hqRk0UpteIvoUSommkSMyhnXFfSg-jyt/view. (In Russ). - Bosch E, Broer S, Griesinger G, et al. ESHRE guideline: ovarian stimulation for IVF/ICSI. Hum Reprod Open. 2020;2020(2):hoaa009. EDN: CBCDVP doi: 10.1093/hropen/hoaa009 - Iwami N, Kawamata M, Ozawa N, et al. New treatment strategy for endometriosis using progestin-primed ovarian stimulation with dienogest: a prospective cohort study, comparison of dienogest versus dydrogesterone. Reprod Biol. 2021;21(1):100470. EDN: RSIIEM doi: 10.1016/j.repbio.2020.100470 - Mathieu D’Argent E, Ferrier C, Zacharopoulou C, et al. Outcomes of fertility preservation in women with endometriosis: comparison of progestin-primed ovarian stimulation versus antagonist protocols. J Ovarian Res. 2020;13(1):18. EDN: FZTUDU doi: 10.1186/s13048-020-00620-z - Somigliana E, Li Piani L, Paffoni A, et al. Endometriosis and IVF treatment outcomes: unpacking the process. Reprod Biol Endocrinol. 2023;21(1):107. EDN: PAMEUE doi: 10.1186/s12958-023-01157-8

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