Evidence map›Paper›PMID 37194068›Full record

ArticleReproductive biology and endocrinology : RB&E2023

Live birth rates following individualized dosing algorithm of follitropin delta in a long GnRH agonist protocol.

Manuel Fernández Sánchez, Per Larsson, Marcos Ferrando Serrano, Ernesto Bosch, Juan Antonio García Velasco, Esther Santamaría López, Bernadette Mannaerts

Registry-linked trialOpen access · goldAbstract read
In one paragraph

Article in Reproductive biology and endocrinology : RB&E, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03564509 (A Randomised, Double-blind, Placebo-controlled, Parallel-group, Dose-range Trial to Investigate the Efficacy and Safety of FE 999302 as add-on Treatment to Follitropin Delta), which is not on this map. Cited by 5 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed, 4 pooled it
1.6field-weighted citation impact, top 16% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03564509 phase2completednot on this map

A Randomised, Double-blind, Placebo-controlled, Parallel-group, Dose-range Trial to Investigate the Efficacy and Safety of FE 999302 as add-on Treatment to Follitropin Delta (REKOVELLE) in Women Undergoing Controlled Ovarian Stimulation in a Long GnRH Agonist Protocol

TypeinterventionalSponsorFerring PharmaceuticalsRan2018 to 2020Enrolled620ConditionsControlled Ovarian StimulationArmsFE 999302 (1 μg) and follitropin delta, FE 999302 (2 μg) and follitropin delta, FE 999302 (4 μg) and follitropin delta, FE 999302 (8 μg) and follitropin delta, FE 999302 (12 μg) and follitropin delta
3 · Its place in the literature

Who cites it

5 citing papers in PubMed, 4 syntheses or guidelines pooled it, 6 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Pooled it
  5. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

7 authors at 5 institutions in 2 countries.

Manuel Fernández SánchezIVI-RMA Seville, Avenida Americo Vespucio 19, Seville, ES-41092, Spain. manuel.fernandez@ivirma.com.
Per LarssonGlobal Biometrics, Ferring Pharmaceuticals A/S, Amager Strandvej 405, Kastrup, 2770, Denmark.
Marcos Ferrando SerranoFundacion IVI, Instituto Investigación Sanitaria La Fe, Valencia, ES-46026, Spain.
Ernesto BoschFundacion IVI, Instituto Investigación Sanitaria La Fe, Valencia, ES-46026, Spain.
Juan Antonio García VelascoFundacion IVI, Instituto Investigación Sanitaria La Fe, Valencia, ES-46026, Spain.
Esther Santamaría LópezIVI-RMA Seville, Avenida Americo Vespucio 19, Seville, ES-41092, Spain.
Bernadette MannaertsReproductive Medicine & Maternal Health, Ferring Pharmaceuticals A/S, Amager Strandvej 405, Kastrup, 2770, Denmark.
Ferring Pharmaceuticals (Denmark) · DKIVI Sevilla Clinic · ESAyuntamiento de Bilbao · ESIVI Madrid Clinic · ESValencian Infertility Institute · ES

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeTo explore the efficacy and safety of individualized follitropin delta dosing, based on serum anti-Müllerian hormone (AMH) concentration and bodyweight, in a long gonadotropin-releasing hormone (GnRH) agonist protocol.

methodsClinical outcomes after one treatment cycle are reported in women with AMH: 5-35 pmol/L. Oocytes were inseminated by intracytoplasmic sperm injection, blastocyst transfer was on Day 5 and remaining blastocysts were cryopreserved. Data collection included live births and neonatal health follow-up for all fresh/frozen transfers performed within one year after treatment allocation.

resultsIn total, 104 women started stimulation, of whom 101 had oocyte recovery and 92 had blastocyst transfer. The average daily dose of follitropin delta was 11.0 ± 1.6 µg and the duration of stimulation was 10.3 ± 1.6 days. The mean number of oocytes was 12.5 ± 6.4, the mean number of blastocysts was 5.1 ± 3.4, and 85% had at least one good-quality blastocyst. Following mostly single blastocyst transfer (95%), the ongoing pregnancy rate was 43%, the live-birth rate was 43%, and the cumulative live-birth rate was 58% per started stimulation. There were 6 cases of early OHSS (5.8%) graded as mild (n = 3) and moderate (n = 3) and 6 cases of late OHSS (5.8%) graded as moderate (n = 3) and severe (n = 3).

conclusionIn this first evaluation of the individualized follitropin delta dosing in a long GnRH agonist protocol, the cumulative live-birth rate was high. A randomized trial comparing follitropin delta in a long GnRH agonist protocol versus in a GnRH antagonist protocol should provide further insight into the efficacy and safety of this treatment option. TRIAL REGISTRATION NUMBER: NCT03564509; June 21, 2018.

Indexed as

Birth RateOvarian Hyperstimulation SyndromeFemaleFertilization in VitroFollicle Stimulating Hormone, HumanGonadotropin-Releasing HormoneHumansLive BirthMaleOvulation InductionPregnancyPregnancy RateRecombinant ProteinsSemenFollicle Stimulating Hormone, Humanfollitropin deltaGonadotropin-Releasing HormoneRecombinant ProteinsCumulative live birth ratesFollitropin deltaIndividualized dosingLong GnRH agonist

Identifiers

PMID37194068
PMCPMC10185461
OpenAlexW4376871241

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.