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Infertility, FemalePhase 4NCT04643925

hCG Priming in Women With Low Ovarian Reserve

A Phase 4 study testing Ovitrelle in people with Infertility, Female and Ovarian Reserve, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 40 years, women only
What is being tested?
Ovitrelle
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteDenmark
Study dates
27 Dec 2020to 31 Aug 2021
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 40 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

  • Regular menstrual cycle (23-35 days)
  • 1.-5. IVF/ICSI cycle at inclusion
  • AMH < 6.29 pmol/L (Elecsys® AMH assay)

Who cannot join

  • Uterine malformations or hydrosalpinx
  • Submucosal uterine myomas
  • Uterine polyps
  • Allergy to standard IVF/ICSI medication
  • Endometriosis stage III-IV
  • Severe comorbidity
Show all 10Show fewer
  • Preimplantation genetic testing
  • Testicular sperm aspiration/extraction
  • Tumors in the hypothalamus or pituitary gland
  • Active thromboembolic disease

Trial locations and contacts

1 site in 1 country.

Denmark1 site

  • Rigshospitalet

    København Ø, 2100

Other trials in Denmark

About this study

Official title: Eight Weeks of Androgen Priming by hCG Before IVF/ICSI in Women With Low Ovarian Reserve

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.

Read the detailed description

One of the fundamental goals in In Vitro Fertilisation (IVF) is obtaining a high number of good quality oocytes, in order to select and transfer embryos with the highest possible implantation potential thereby optimizing the chance of a pregnancy and ultimately a live birth. This is done by applying an individualized controlled ovarian stimulation (iCOS) protocol, primarily based on ovarian reserve markers like antral follicle count (AFC) and Anti-Müllerian hormone (AMH), when deciding the follicle stimulating hormone (FSH) stimulation dose. Certain patients, the so called "poor ovarian responders' (PORs), pose a clinical challenge because they have a poor ovarian reserve and develop a limited number of pre-ovulatory follicles in respond to ovarian stimulation despite high FSH stimulation doses, thus experiencing reduced live birth rates.

The aim of the present study is to examine the possible effects of long-term LH activity by the administration of hCG for eight weeks in between two identical IVF/ICSI cycles and compare cycle characteristics and outcome. The primary outcome is the follicular output rate (FORT) which reflects the proportion of antral follicles at the start of controlled ovarian stimulation that reaches the pre-ovulatory state. Secondary outcomes include amongst others AMH and antral follicle count at baseline (cd 2-3), number of pre-ovulatory follicles, oocytes retrieved, and embryos developed.

We hypothesize that eight weeks of androgen priming by hCG increases the proportion of antral follicles that reaches the pre-ovulatory state during controlled ovarian stimulation for IVF/ICSI in women with poor ovarian reserve.

Being tested
Ovitrelle
Keywords
IVF, Poor ovarian reserve, Controlled ovarian stimulation, Ovarian stimulation, hCG priming
Medical subject headings
Infertility, Female

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • OvitrelleDrug

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

Study groups in NCT04643925
Study groupRoleWhat they receive
hCG primingExperimentalControl 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.
Receives: Drug: Ovitrelle

What is being measured

The primary outcome is the main question the study is designed to answer.

  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).

    Measured: Through study completion, an average of 5 months

Secondary outcomes (18)

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

    Measured: Through study completion, an average of 5 months

  2. AMH at baseline (CD 2-3)

    Measured: Through study completion, an average of 5 months

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

    Measured: Through study completion, an average of 5 months

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

    Measured: Through study completion, an average of 5 months

  5. Number of oocytes retrieved

    Measured: Through study completion, an average of 5 months

  6. Number of mature (MII) oocytes

    Measured: Through study completion, an average of 5 months

  7. Number of fertilized eggs (2pn)

    Measured: Through study completion, an average of 5 months

  8. Number of cleaved day 2 embryos

    Measured: Through study completion, an average of 5 months

  9. Number of good quality day 2 embryos

    Measured: Through study completion, an average of 5 months

  10. Number of top quality day 2 embryos

    Measured: Through study completion, an average of 5 months

  11. Number of blastocysts (Gardner score 1-6)

    Measured: Through study completion, an average of 5 months

  12. Number of good quality blastocysts day 5/6

    Measured: Through study completion, an average of 5 months

  13. Number of vitrified embryos/blastocysts

    Measured: Through study completion, an average of 5 months

  14. Total number of transferred or vitrified blastocysts

    Measured: Through study completion, an average of 5 months

  15. The number of cancelled cycles and the reasons for cancellation in the two groups

    Measured: Through study completion, an average of 5 months

  16. Serum and follicular fluid hormonal levels (AMH, estradiol, progesterone, 17-OH-progesterone, hCG, LH, FSH, testosterone, androstenedione and Inhibin B

    Measured: Through study completion, an average of 5 months

  17. Granulosa/cumulus cell FSH and LH receptor expression

    Measured: 1 year

  18. Cumulus/corona gene expression analysis by quantitative PCR using three predictive genes (EFNB2, SASH1, CAMK1D).

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Nov 2020
  2. Study start27 Dec 2020
  3. Primary completion31 Aug 2021
  4. Study completion31 Aug 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
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.
Masking
None (open label)
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04643925
Sponsor's protocol ID
73908
Status last verified
Aug 2022
First submitted
4 Nov 2020
Last updated
25 Aug 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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.

Publications

  • 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.

    PubMed 37354554

  • 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.

    PubMed 36721920

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Ovitrelle in people with Infertility, Female and Ovarian Reserve, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Follicular output rate (time frame: Through study completion, an average of 5 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04643925, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2022.

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