NCT04643925

Brief Summary

The aim of this trial is to examine the possible effects of hCG administration for eight weeks prior to IVF/ICSI in women with low ovarian reserve. Primary outcome is the proportion of the antral follicle count that reach the pre-ovulatory stage.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Dec 2020

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 4, 2020

Completed
21 days until next milestone

First Posted

Study publicly available on registry

November 25, 2020

Completed
1 month until next milestone

Study Start

First participant enrolled

December 27, 2020

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2021

Completed
Last Updated

August 25, 2022

Status Verified

August 1, 2022

Enrollment Period

8 months

First QC Date

November 4, 2020

Last Update Submit

August 24, 2022

Conditions

Infertility, FemaleOvarian ReserveIn Vitro Fertilization

Keywords

IVFPoor ovarian reserveControlled ovarian stimulationOvarian stimulationhCG priming

Outcome Measures

Primary Outcomes (1)

  • Follicular output rate

    Follicular Output Rate (FORT: pre-ovulatory follicle count (\>16 mm) at hCG trigger day/antral follicle count at baseline (2-10 mm).

    Through study completion, an average of 5 months

Secondary Outcomes (18)

  • Antral follicle count (≤10 mm) at baseline (cd 2-3)

    Through study completion, an average of 5 months

  • AMH at baseline (CD 2-3)

    Through study completion, an average of 5 months

  • Number of pre-ovulatory follicles >16 mm on trigger day

    Through study completion, an average of 5 months

  • Number of follicles >14 mm and >12 mm, >10 mm and ≤10 mm on hCG trigger day

    Through study completion, an average of 5 months

  • Number of oocytes retrieved

    Through study completion, an average of 5 months

  • +13 more secondary outcomes

Study Arms (1)

hCG priming

EXPERIMENTAL

Control cycle: A standard IVF/ICSI cycle in the fixed GnRH-antagonist protocol using a daily dose of 300 IU rFSH initiated from cd 2-3 and the GnRH antagonist (Fyremadel 0.25 mg) from stimulation day 5-6 followed by blastocyst culture and a freeze-all strategy. Study cycle: hCG priming by Ovitrelle 260 IE once daily for 8 weeks followed by a standard IVF/ICSI cycle in the fixed GnRH-antagonist protocol using a daily dose of 300 IU rFSH initiated from cd 2-3 and the GnRH antagonist (Fyremadel 0.25 mg) from stimulation day 5-6 followed by a single blastocyst transfer at day 5.

Drug: Ovitrelle

Interventions

OvitrelleDRUG

Ovitrelle 260 IE once daily for 8 weeks prior to IVF/ICSI

hCG priming

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Regular menstrual cycle (23-35 days)
  • AMH \< 6.29 pmol/L (Elecsys® AMH assay)

You may not qualify if:

  • Uterine malformations or hydrosalpinx
  • Submucosal uterine myomas
  • Uterine polyps
  • Allergy to standard IVF/ICSI medication
  • Endometriosis stage III-IV
  • Severe comorbidity
  • Preimplantation genetic testing
  • Testicular sperm aspiration/extraction
  • Tumors in the hypothalamus or pituitary gland
  • Active thromboembolic disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rigshospitalet

København Ø, 2100, Denmark

Location

Related Publications (2)

  • Friis Wang N, Bogstad JW, Petersen MR, Pinborg A, Yding Andersen C, Lossl K. Androgen and inhibin B levels during ovarian stimulation before and after 8 weeks of low-dose hCG priming in women with low ovarian reserve. Hum Reprod. 2023 Sep 5;38(9):1807-1815. doi: 10.1093/humrep/dead134.

    PMID: 37354554DERIVED

  • Friis Wang N, Bogstad JW, Pors SE, Petersen MR, Pinborg A, Yding Andersen C, Lossl K. Eight weeks of androgen priming by daily low-dose hCG injections before ICSI treatment in women with low ovarian reserve. Hum Reprod. 2023 Apr 3;38(4):716-725. doi: 10.1093/humrep/dead012.

    PMID: 36721920DERIVED

MeSH Terms

Conditions

Infertility, Female

Interventions

Chorionic Gonadotropin

Condition Hierarchy (Ancestors)

Genital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesInfertility

Intervention Hierarchy (Ancestors)

GonadotropinsPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPlacental HormonesPeptidesAmino Acids, Peptides, and ProteinsPregnancy ProteinsProteins

Study Officials

  • Anja B Pinborg, MD

    The Fertility Department, Rigshospitalet

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Women will undergo two identical consecutive IVF/ICSI treatments: a Control cycle including blastocyst culture and freeze-all and a subsequent identical Study cycle, separated by eight weeks of androgen priming by daily hCG-injections. Both IVF/ICSI cycles are performed in the fixed GnRH-antagonist protocol using a daily dose of 300 IU rFSH initiated from cd 2-3 and the GnRH antagonist (Fyremadel 0.25 mg) from stimulation day 5-6.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Consultant, PhD

Study Record Dates

First Submitted

November 4, 2020

First Posted

November 25, 2020

Study Start

December 27, 2020

Primary Completion

August 31, 2021

Study Completion

August 31, 2021

Last Updated

August 25, 2022

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will share

On request, the study protocol and unidentifiable individual study data collected during the trial, including stored biobank samples, can be shared with research groups with relevant aims and a methodologically sound proposal. Approvals by necessary ethic committees and the Danish Data Protection Agency will be needed before sharing of data. All costs for data sharing will be covered by the party requesting the data. Data cannot be shared with groups working on research projects with the same aims, secondary aims or purposes. Furthermore, no data can be shared until 3 months after publication of first papers on the primary and secondary outcomes in this study. Biobank samples cannot be shared with research groups outside Denmark. Proposals of data sharing should be directed to anja.bisgaard.pinborg@regionh.dk. To gain access, data requestors will need to sign a data sharing agreement.

Shared Documents
STUDY PROTOCOL

Locations

DK(1)