Optimizing the fertility potential for boys with doublesided undescended testes by supplementary hormonal treatment.

Optimizing the fertility potential of bilateral cryptorchidism by treatment with adjuvant kryptocur. - adjuvant kryptokur treatment

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2019-004458-27-DK

Enrollment

Registered

2019-12-13

Start date

2021-01-21

Completion date

Unknown

Last updated

2024-08-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cryptorchidism MedDRA version: 20.0 Level: LLT Classification code 10056600 Term: Cryptorchidism System Organ Class: 100000004850

Interventions

Trade Name: Kryptocur Product Name: Kryptocur Product Code: drug ID: 27415193612 Pharmaceutical Form: Nasal spray, solution INN or Proposed INN: GONADORELIN CAS Number: 33515-09-2 Current Sponsor code

Eligibility

Sex/Gender

Male

Inclusion criteria

Inclusion criteria: Bilateral cryptorchidism in 52 boys from 6 to 36 months of age at time of surgery. The germ cell number per tubular transverse section in testicular biopsies should be mean 0.2 to 0.5 and PLAP (placental alkaline phosphatase) positive germ cells should be present. The estimation of germ cell count is performed according to a method from our laboratory previously published . Serum levels of FSH and LH must not be increased above normal range . Are the trial subjects under 18? yes Number of subjects for this age range: 52 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Another significant abnormality or earlier inguinal operation.

Design outcomes

Primary

Measure	Time frame
Main Objective: The project aims to improve the fertility potential for patients operated in early infancy for bilateral cryptorchidism but still having a high risk of infertility due to an underlying endocrinopathy. Furthermore, the aim of the study is to show that this selected group of bilateral cryptorchid boys with high risk of infertility, despite early surgery for undescended testes, will benefit from adjuvant postoperative hormone therapy and in case of treatment failure to rescue germ cells by cryopreservation, while germ cells are still present in the undescended testes.;Secondary Objective: Not applicable;Primary end point(s): Evaluation: The effect of gonadotropin therapy is estimated by evaluation of the testis histopathology, estimation of the number of germ cells per tubular transverse section, presence of adult dark spermatogonia and hormone profile by 9 - 12 months of follow-up. Success criteria include the normalization of the germ cell number with significant increase in the kryptocur® group compared to the placebo group, presence of adult dark spermatogonia and normal serum inhibin- B.;Timepoint(s) of evaluation of this end point: When all data are available after last subject has completed the study, it will befinalized. Expected end of 2024	—

Measure

Time frame

Main Objective: The project aims to improve the fertility potential for patients operated in early infancy for bilateral cryptorchidism but still having a high risk of infertility due to an underlying endocrinopathy. Furthermore, the aim of the study is to show that this selected group of bilateral cryptorchid boys with high risk of infertility, despite early surgery for undescended testes, will benefit from adjuvant postoperative hormone therapy and in case of treatment failure to rescue germ cells by cryopreservation, while germ cells are still present in the undescended testes.;Secondary Objective: Not applicable;Primary end point(s): Evaluation: The effect of gonadotropin therapy is estimated by evaluation of the testis histopathology, estimation of the number of germ cells per tubular transverse section, presence of adult dark spermatogonia and hormone profile by 9 - 12 months of follow-up. Success criteria include the normalization of the germ cell number with significant increase in the kryptocur® group compared to the placebo group, presence of adult dark spermatogonia and normal serum inhibin- B.;Timepoint(s) of evaluation of this end point: When all data are available after last subject has completed the study, it will befinalized. Expected end of 2024

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Secondary

Measure	Time frame
Secondary end point(s): Not applicable;Timepoint(s) of evaluation of this end point: Not applicable	—

Countries

Denmark

Contacts

Public ContactRigshospitalet

Rigshospitalet

j-thorup@rh.dk4535458541

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026