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Letrozole vs. Clomiphene Citrate Plus Tamoxifen for Ovulation Induction and Pregnancy Outcomes. (LET-CC-TAM)

28. mai 2026 oppdatert av: Ghada Abdullatef Mahmood Al-Rajami, Sana'a University

Letrozole Versus Clomiphene Citrate Plus Tamoxifen for Ovulation Induction and Pregnancy Outcomes in Infertile Women: A Randomized Clinical Trial

Infertility is a common reproductive health problem. Ovulation induction is a key treatment for women with anovulatory infertility. Letrozole and clomiphene citrate are widely used medications for ovulation induction. Tamoxifen has also been used as an alternative or adjunct therapy.

This randomized clinical trial aims to compare the effectiveness of letrozole versus clomiphene citrate combined with tamoxifen for ovulation induction and pregnancy outcomes in infertile women. The outcomes include ovulation rate, pregnancy rate, endometrial thickness, follicular development, Miscarriage rate, and Live birth rate.

The study will be conducted at Al-Thawra Hospital in Sana'a, Yemen, under the supervision of Sana'a University.

Keywords: Infertility, Ovulation Induction, Letrozole, Clomiphene Citrate, Tamoxifen

Studieoversikt

Status

Aktiv, ikke rekrutterende

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

Infertility affects a significant proportion of women worldwide and is often associated with ovulatory dysfunction. While letrozole and clomiphene citrate are standard treatments for ovulation induction, their comparative effectiveness alongside tamoxifen as adjunct therapy remains under investigation.

Infertility affects a significant proportion of women worldwide and is often associated with ovulatory dysfunction. While letrozole and clomiphene citrate are standard treatments for ovulation induction, their comparative effectiveness alongside tamoxifen as adjunct therapy remains under investigation.

This study is a randomized clinical trial enrolling women with anovulatory infertility. Participants will be assigned to receive either letrozole alone or clomiphene citrate combined with tamoxifen. Ovulation will be monitored using ultrasound and hormonal assays. Pregnancy outcomes will be recorded and analyzed to compare efficacy between the two treatment groups.

Endometrial thickness and follicular development will be evaluated throughout the treatment cycles. All participants provide informed consent before enrollment, and the study is conducted under the approval of the Sana'a University Ethics Committee at Al-Thawra Hospital, Sana'a, Yemen.

Studietype

Intervensjonell

Registrering (Faktiske)

240

Fase

  • Fase 3

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Jemen
    • Sana'a
      • Sanaa, Sana'a, Jemen
        • Al-Thawra Hospital

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen

Tar imot friske frivillige

Nei

Beskrivelse

Inclusion Criteria:

  • Women aged between 18 and 40 years.
  • Patients with anovulatory polycystic ovaries.
  • Presence of a normal uterus and patent fallopian tubes, as confirmed by hysterosalpingography (HSG).
  • Husband's semen analysis within normal parameters.
  • Normal serum prolactin and thyroid-stimulating hormone (TSH) levels.

Exclusion Criteria:

  • Spontaneous pregnancy.
  • Women with hyperprolactinemia or thyroid dysfunction.
  • Active liver disease or renal disease.
  • Documented pelvic diseases such as endometriosis, ovarian pathology, hydro- or pyosalpinx, or uterine fibroids.
  • Previous history of ovarian drilling.
  • Contraindications to letrozole, clomiphene citrate, or tamoxifen.
  • History of hypersensitivity reactions to study medications.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Letrazole Group
Participants receive letrazole for ovulation induction according to the study protocol and are followed to evaluate ovulation and pregnancy outcomes.
Legemiddel: Letrozole
Letrozole was administered for ovulation induction in infertile women according to the study protocol.
Eksperimentell: Clomiphene Citrate + Tamoxifen
Participants receive Clomiphene citrate and tamoxifen for ovulatory induction according to the study protocol and are followed to assess ovulatory and pregnancy outcomes.
Legemiddel: Clomiphene Citrate + Tamoxifen
Clomiphene citrate combined with tamoxifen was administered for ovulation induction in infertile women according to the study protocol.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Ovulation rate
Tidsramme: During three treatment cycles, from days 10 to 16 of each cycle, adjustments will be made based on individual variations in menstrual cycle length (cycle length: 21-35 days).
The primary outcome is the rate of ovulation among participants, assessed by ultrasound monitoring of follicular development and serum hormone levels.
During three treatment cycles, from days 10 to 16 of each cycle, adjustments will be made based on individual variations in menstrual cycle length (cycle length: 21-35 days).

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
clinical pregnancy rate .
Tidsramme: Pregnancy was confirmed in three treatment cycles (cycle length 21-35 days) through serum beta-hCG testing two weeks post-ovulation, followed by a transvaginal ultrasound showing a gestational sac four to six weeks later.
presence of a clinical pregnancy confirmed by transvaginal ultrasound visualization of a gestational sac with fetal heartbeat after ovulation induction treatment.
Pregnancy was confirmed in three treatment cycles (cycle length 21-35 days) through serum beta-hCG testing two weeks post-ovulation, followed by a transvaginal ultrasound showing a gestational sac four to six weeks later.
Endometrial thickness
Tidsramme: During each of the three treatment cycles, from cycle day 10 until the administration of the ovulation trigger, adjustments were made based on individual variations in menstrual cycle length(21-35 days).
Measurement of Endometrial thickness in millimeters using transvaginal ultrasound on the day of ovulation trigger during ovulation induction treatment cycles.
During each of the three treatment cycles, from cycle day 10 until the administration of the ovulation trigger, adjustments were made based on individual variations in menstrual cycle length(21-35 days).
Adverse Events/ Side effect
Tidsramme: From day 2 of the menstrual cycle (initiation of ovulation induction treatment) through up to 3 treatment cycles (cycle length: 21-35 days), until 2 weeks after the ovulation trigger.
Incidence of adverse events (CTCAE v5.0 grades 1-3 ), including nausea, headache, hot flushes, and ovarian hyperstimulation syndrome ( OHSS), was assessed by patient questionnaire per ovulation induction cycles.
From day 2 of the menstrual cycle (initiation of ovulation induction treatment) through up to 3 treatment cycles (cycle length: 21-35 days), until 2 weeks after the ovulation trigger.

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Sana'a University

Samarbeidspartnere

Al-Thawra Modern General Hospital

Etterforskere

  • Hovedetterforsker: Ghada Abdullatef Al-Rajami, MD, Sana'a University

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

1. mai 2023

Primær fullføring (Antatt)

30. mai 2026

Studiet fullført (Antatt)

30. mai 2026

Datoer for studieregistrering

Først innsendt

20. mai 2026

Først innsendt som oppfylte QC-kriteriene

28. mai 2026

Først lagt ut (Faktiske)

1. juni 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

1. juni 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

28. mai 2026

Sist bekreftet

1. mars 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • SANA2023-LECLO03

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

IPD-planbeskrivelse

The study involves sensitive clinical information of infertile women, and sharing these data compromises participant privacy and confidentiality.

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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